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Manvelian G.,Iroko Pharmaceuticals | Daniels S.,Premier Research Group International LLC | Gibofsky A.,Hospital for Special Surgery
Pain Medicine (United States) | Year: 2012

Background. Safety concerns associated with nonsteroidal anti-inflammatory drugs (NSAIDs) have prompted the development of new formulations that minimize adverse events (AEs) and maintain efficacy. Objectives. To determine the analgesic efficacy and safety of an investigational, proprietary, nano-formulated, oral diclofenac (nano-formulated diclofenac) compared with placebo in subjects with acute dental pain. Methods. A Phase 2, multisite, randomized, double-blind, single-dose, parallel-group, active- and placebo-controlled study was carried out in 202 subjects (18-50 years old) who had extraction of ≥2 third molars (≥1 had to be a fully or partially impacted mandibular third molar) and experienced moderate to severe pain intensity ≤6 hours postsurgery (NCT00985439). Subjects received nano-formulated diclofenac 35mg or 18mg, celecoxib 400mg, or placebo. The primary efficacy variable was the sum of total pain relief (TOTPAR) over 0-12 hours (TOTPAR-12) after Time 0. Secondary end points included TOTPAR over 0-4 hours (TOTPAR-4), TOTPAR over 0-8 hours (TOTPAR-8), and time to onset of analgesia. Results. Mean±standard deviation TOTPAR-12 for nano-formulated diclofenac 35mg and 18mg, celecoxib, and placebo were 16.81±12.76, 17.76±13.76, 14.61±15.05, and 5.65±11.53, respectively (P<0.001, nano-formulated diclofenac compared with placebo). Similar improvements were observed for TOTPAR-4, TOTPAR-8, mean time to first perceptible pain relief (P<0.001), and peak relief (P<0.05). Celecoxib treatment was not statistically different than placebo for these latter two parameters. Treatment-emergent AEs were similar across all treatment groups. Conclusions. Lower dose, nano-formulated diclofenac demonstrated good overall efficacy, prompt pain relief, and was well tolerated. These data suggest lower dose nano-formulated NSAIDs could be effective for acute pain and may potentially improve safety and tolerability as a result of using a lower overall dose. © 2012 American Academy of Pain Medicine.


Gibofsky A.,Cornell University | Hochberg M.C.,University of Maryland, Baltimore | Jaros M.J.,Summit Analytical LLC | Young C.L.,Iroko Pharmaceuticals
Current Medical Research and Opinion | Year: 2014

Objective: NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology*), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35mg three times daily (tid) and twice daily (bid) in patients with OA pain. Research design and methods: This double-blind study enrolled patients ≥40 years of age with clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale scores ≥40mm by visual analog scale and an OA flare (≥15mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35mg tid, submicron diclofenac 35mg bid, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01461369. Main outcome measures: Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 (primary efficacy parameter) and in average total WOMAC score over 12 weeks. Results: Submicron diclofenac 35mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks (-44.1; p=0.0024) compared with placebo (-32.5). Submicron diclofenac 35mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance (-39.0; p=0.0795) compared with placebo. Submicron diclofenac 35mg tid (-35.9; p=0.0002) and 35mg bid (-30.3; p=0.0363) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo (-23.2). The most frequent AEs in the submicron diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (OA 'flare') at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups. Conclusions: Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain. © 2014 Informa UK Ltd.


Trademark
Iroko Pharmaceuticals and Iroko Properties Inc. | Date: 2016-03-08

Pharmaceutical preparations for the treatment of pain and pain associated with inflammation.


Trademark
Iroko Properties Inc. and Iroko Pharmaceuticals | Date: 2014-04-01

Pharmaceutical preparations for the treatment of pain and pain associated with inflammation.


V

Trademark
Iroko Pharmaceuticals | Date: 2015-11-06

Pharmaceutical preparations for the treatment of pain and pain associated with inflammation.


PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals Inc., a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced the initiation of a licensing agreement with Litha Pharma Proprietary Limited, a subsidiary of Litha Healthcare Group (“Litha”) for the exclusive rights to market and sell ZORVOLEX® (diclofenac) capsules in specified countries in East and Southern Africa. Litha will be responsible for obtaining regulatory and pricing approval as well as provide marketing and distribution in countries including Angola, Botswana, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Republic of South Africa, Seychelles, Swaziland, Tanzania and Zambia. “Our partnership with Litha marks the seventh international licensing agreement for ZORVOLEX, our first low dose NSAID developed with the SoluMatrix Fine Particle Technology™,” said Osagie Imasogie, Executive Chairman of the Board and Chief Executive Officer of Iroko Pharmaceuticals. “Through these agreements, Iroko has expanded potential commercialization opportunities for ZORVOLEX across five continents: North America, South America, Africa, Asia and Australia.” ZORVOLEX is approved by the United States Food and Drug Administration (FDA) for the management of mild to moderate acute pain and osteoarthritis pain, and is available at pharmacies across the United States1. ZORVOLEX was also recently approved by the Republic of Lebanon Ministry of Public Health (MOPH) for these indications2,3. “We are delighted to work with Iroko to make ZORVOLEX available in the 13 countries covered by this agreement and look forward to a fruitful partnership,” said Norbert Oppitz, Regional Vice President, Latin America, Africa and Export Markets for Endo International plc., holding company of Litha. Current licensing agreements for ZORVOLEX cover countries in the Middle East North Africa (MENA) region, Australia and New Zealand, Indonesia, and countries in Latin America, including the Central America region, Colombia, Venezuela, Mexico and Brazil. Iroko is in discussions with additional potential distribution and marketing partners in other international markets. Iroko Pharmaceuticals, LLC, an affiliate of Iroko Pharmaceuticals Inc., will continue to retain all marketing rights to ZORVOLEX in the U.S. About ZORVOLEX ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com. ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen. NSAIDs, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists. Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX in patients with advanced renal disease is not recommended. Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur. Starting at 30 weeks’ gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding that is higher than in users of either drug alone. Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia. ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX. Please see full Prescribing Information for additional important safety and dosing information. About Litha Healthcare Group Litha is a diversified healthcare group providing services, products and solutions to public and private hospitals, pharmacies, general and specialist practitioners, as well as government healthcare programmes, headquartered in Midrand, South Africa. Paladin Labs Inc., an indirect subsidiary of Endo International plc acquired all of the remaining shares in Litha in February 2015. Litha’s leadership team brings together a group of highly regarded professionals with many years of experience within the South African healthcare sector and now benefits from the expertise and product pipeline available through its holding company, Endo International plc. Litha Healthcare Group’s operations are focused on harnessing its unique product offering to achieve its company Mission of, “actively participating in and contributing to the creation of a healthier society, through the provision of integrated healthcare.” Litha is an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL), a global specialty healthcare company focused on improving patients’ lives while creating shareholder value. Learn more at www.endo.com. About Litha Pharma Litha Pharma is a division of Litha Healthcare Group and has been a key strategic area of growth for the Group since 2012 when it was acquired and merged with Pharmaplan. Litha Pharma has numerous license agreements, co-marketing and joint ventures with international healthcare companies and will continue to pursue additional opportunities that are a strategic fit. Access and ownership to product pipelines is an intrinsic part of its long-term strategy and Litha Pharma has many exciting new products in various stages of registration at the Medicines Control Council. About Iroko Pharmaceuticals, LLC Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. ZORVOLEX is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA. For more information, visit www.iroko.com. SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko.


News Article | May 14, 2015
Site: www.businesswire.com

PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals Inc., a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that ZORVOLEX® (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), is now available in 18 mg and 35 mg dosage strengths by prescription in Lebanon. ZORVOLEX was approved by the Republic of Lebanon Ministry of Public Health (MOPH) as a new chemical entity in December 2014 for the treatment of mild to moderate acute pain in adults and osteoarthritis pain1,2. “We are pleased to announce that ZORVOLEX is now available in Lebanon for both acute and chronic pain conditions, providing a low dose treatment option to patients and prescribers in the country,” said Osagie Imasogie, Executive Chairman of the Iroko Board and Chief Executive Officer. “This first international launch of ZORVOLEX demonstrates our commitment to working with global partners to commercialize ZORVOLEX, and marks an important step in bringing our low dose NSAIDs to patients around the world.” This approval was the result of a licensing agreement signed in late 2013 by Iroko Pharmaceuticals Inc. and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to register and market ZORVOLEX in countries in the Middle East and North Africa (MENA). Algorithm is planning to submit product registration applications for ZORVOLEX to other countries across the MENA region this year and next. “We are proud to partner with Iroko to make ZORVOLEX available in Lebanon and look forward to working towards bringing the product to other countries in the region,” said Selim Ghorayeb, CEO of Algorithm. ZORVOLEX is approved by the U.S. Food and Drug Administration (FDA) for the management of mild to moderate acute and osteoarthritis pain, and is available at pharmacies across the United States3. Iroko Pharmaceuticals, LLC, an affiliate of Iroko Pharmaceuticals Inc., will continue to retain all marketing rights to ZORVOLEX in the U.S. Since late 2013, Iroko Pharmaceuticals Inc., has entered into strategic agreements with pharmaceutical companies worldwide, who are obtaining the exclusive rights to market ZORVOLEX within their regions, and is in discussions with additional companies to bring ZORVOLEX to other international markets. Current agreements cover several countries in the MENA, Latin America and Asia-Pacific regions. About ZORVOLEX ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com. ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen. NSAIDs, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists. Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX in patients with advanced renal disease is not recommended. Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur. Starting at 30 weeks’ gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding that is higher than in users of either drug alone. Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia. ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX. Please see full Prescribing Information for additional important safety and dosing information. About Algorithm S.A.L. Algorithm, a Lebanon-based pharmaceutical manufacturer, is actively present in the MENA region and Cyprus. Algorithm is dedicated to offering quality products, either under license from reputable international companies or developed by the company’s product development team. The portfolio consists of innovative products as well as differentiated generics, focusing mainly on the following therapeutic areas: Cardiometabolic Diseases, Ortho-Rheumatology, Neurology, Onco-Hematology, Endocrinology, Uro-Gynecology, and Dermatology. For more information, visit www.algorithm-lb.com/en_Home. About Iroko Pharmaceuticals, LLC Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. ZORVOLEX is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA. For more information, visit www.iroko.com. SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko. 1 Lebanon Ministry of Health Approval Document for ZORVOLEX 18 mg. 2 Lebanon Ministry of Health Approval Document for ZORVOLEX 35 mg. 3 Prescribing Information for ZORVOLEX, pg. 1.


News Article | May 14, 2015
Site: www.businesswire.com

PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals Inc., a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that ZORVOLEX® (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), is now available in 18 mg and 35 mg dosage strengths by prescription in Lebanon. ZORVOLEX was approved by the Republic of Lebanon Ministry of Public Health (MOPH) as a new chemical entity in December 2014 for the treatment of mild to moderate acute pain in adults and osteoarthritis pain1,2. “We are pleased to announce that ZORVOLEX is now available in Lebanon for both acute and chronic pain conditions, providing a low dose treatment option to patients and prescribers in the country,” said Osagie Imasogie, Executive Chairman of the Iroko Board and Chief Executive Officer. “This first international launch of ZORVOLEX demonstrates our commitment to working with global partners to commercialize ZORVOLEX, and marks an important step in bringing our low dose NSAIDs to patients around the world.” This approval was the result of a licensing agreement signed in late 2013 by Iroko Pharmaceuticals Inc. and Algorithm S.A.L. under which Algorithm obtained the exclusive rights to register and market ZORVOLEX in countries in the Middle East and North Africa (MENA). Algorithm is planning to submit product registration applications for ZORVOLEX to other countries across the MENA region this year and next. “We are proud to partner with Iroko to make ZORVOLEX available in Lebanon and look forward to working towards bringing the product to other countries in the region,” said Selim Ghorayeb, CEO of Algorithm. ZORVOLEX is approved by the U.S. Food and Drug Administration (FDA) for the management of mild to moderate acute and osteoarthritis pain, and is available at pharmacies across the United States3. Iroko Pharmaceuticals, LLC, an affiliate of Iroko Pharmaceuticals Inc., will continue to retain all marketing rights to ZORVOLEX in the U.S. Since late 2013, Iroko Pharmaceuticals Inc., has entered into strategic agreements with pharmaceutical companies worldwide, who are obtaining the exclusive rights to market ZORVOLEX within their regions, and is in discussions with additional companies to bring ZORVOLEX to other international markets. Current agreements cover several countries in the MENA, Latin America and Asia-Pacific regions. About ZORVOLEX ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com. ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen. NSAIDs, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists. Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX in patients with advanced renal disease is not recommended. Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur. Starting at 30 weeks’ gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding that is higher than in users of either drug alone. Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia. ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX. Please see full Prescribing Information for additional important safety and dosing information. About Algorithm S.A.L. Algorithm, a Lebanon-based pharmaceutical manufacturer, is actively present in the MENA region and Cyprus. Algorithm is dedicated to offering quality products, either under license from reputable international companies or developed by the company’s product development team. The portfolio consists of innovative products as well as differentiated generics, focusing mainly on the following therapeutic areas: Cardiometabolic Diseases, Ortho-Rheumatology, Neurology, Onco-Hematology, Endocrinology, Uro-Gynecology, and Dermatology. For more information, visit www.algorithm-lb.com/en_Home. About Iroko Pharmaceuticals, LLC Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. ZORVOLEX is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA. For more information, visit www.iroko.com. SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko. 1 Lebanon Ministry of Health Approval Document for ZORVOLEX 18 mg. 2 Lebanon Ministry of Health Approval Document for ZORVOLEX 35 mg. 3 Prescribing Information for ZORVOLEX, pg. 1.


PHILADELPHIA--(BUSINESS WIRE)--Iroko Pharmaceuticals Inc., a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that it has entered into a licensing agreement with LABORATORIOS SAVAL S.A. for the exclusive rights to market and sell ZORVOLEX® (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), in an additional five countries in South America. LABORATORIOS SAVAL S.A. will be responsible for obtaining regulatory and pricing approval as well as provide marketing and distribution in Bolivia, Chile, Ecuador, Paraguay and Peru. Iroko has previously announced international licensing agreements for ZORVOLEX with other partners that cover the South American countries of Brazil, Colombia and Venezuela, as well as Mexico and countries in Central America. “This agreement with LABORATORIOS SAVAL S.A. now means we have partnerships in more than 90 percent of South American territories for ZORVOLEX and will further expand the global reach of Iroko’s first low dose SoluMatrix® NSAID,” said Osagie Imasogie, Executive Chairman of the Board and Chief Executive Officer of Iroko Pharmaceuticals. “With the signing of this agreement, we now have the opportunity to introduce ZORVOLEX in more than 45 countries around the world.” ZORVOLEX is approved by the United States Food and Drug Administration (FDA) for the management of mild to moderate acute pain and osteoarthritis pain, and is available at pharmacies across the U.S.1 ZORVOLEX is also approved by the Republic of Lebanon Ministry of Public Health (MOPH) for these indications, and is now available in 18 mg and 35 mg dosage strengths by prescription2,3. “We are excited to be partnering with Iroko to bring this valuable treatment to South America, where effective low dose options are needed to treat patients suffering from acute and chronic pain conditions,” said Emilio Saval, Chairman and Owner of LABORATORIOS SAVAL S.A. “We hope this partnership will lead to more patients gaining access to an innovative therapeutic treatment option.” Additional licensing agreements for ZORVOLEX cover countries across South America, as well as in the Middle East & North Africa (MENA) region, Southern African countries, Australia and New Zealand, and Indonesia. Iroko is in discussions with additional potential distribution and marketing partners in other international markets. Iroko Pharmaceuticals, LLC, an affiliate of Iroko Pharmaceuticals Inc., will continue to retain all marketing rights to ZORVOLEX in the U.S. About ZORVOLEX ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, ZORVOLEX was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development. For more information, visit www.ZORVOLEX.com. ZORVOLEX is indicated for the management of mild to moderate acute pain and osteoarthritis pain. Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen. NSAIDs, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists. Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX in patients with advanced renal disease is not recommended. Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs. NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur. Starting at 30 weeks’ gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding that is higher than in users of either drug alone. Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia. ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX. Please see full Prescribing Information for additional important safety and dosing information. About LABORATORIOS SAVAL S.A. LABORATORIOS SAVAL S.A. is a family owned pharmaceutical company, with a long and successful history in Chile. During the last decade, LABORATORIOS SAVAL S.A. successfully extended its activities to various countries in Latin America, carrying the same corporate message, which has been its flag in every market: a broad range of products and services that contribute to people’s well-being. Introducing innovative pharmaceutical products to the market is an important element of the corporate philosophy, which has guided the company throughout its impressive trajectory. About Iroko Pharmaceuticals, LLC Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. ZORVOLEX is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA and is also available by prescription in the U.S. For more information, visit www.iroko.com. SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd and is licensed to Iroko. 1 Prescribing Information for ZORVOLEX, pg. 1. 2 Lebanon Ministry of Health Approval Document for ZORVOLEX 18 mg. 3 Lebanon Ministry of Health Approval Document for ZORVOLEX 35 mg.

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