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Hayward, CA, United States

Tepper S.J.,Cleveland Clinic | Chen S.,Impax Laboratories | Reidenbach F.,Caley Reidenbach Consulting | Rapoport A.M.,University of California at Los Angeles
Headache | Year: 2013

Objective.-To review the pharmacokinetics, efficacy, tolerability, and patient acceptance of zolmitriptan nasal spray (NS). Background.-Gastroparesis may delay or diminish the absorption of oral triptans, and nausea or vomiting may do the same and/or make it difficult to take a tablet. Some migraineurs require or prefer faster relief than oral medications provide. Injectable triptans provide the fastest drug delivery into the bloodstream, but many patients are reluctant to use them. Nasal sprays may address some of the problems with tablets and injectables while still providing rapid absorption of drug. Methods.-Non-systematic review. Results.-Significant levels of zolmitriptan NS are detectable in plasma within 2-5 minutes, and the rapid absorption is due to early uptake through the nasal mucosa. In 2 randomized trials, users of zolmitriptan NS were significantly more likely than placebo recipients to be pain-free at 15 minutes post-dose, the first time point measured, and about half of patients had sustained response at 24 hours. Studies in which patients could treat a migraine of any severity have documented significant headache response or relief with zolmitriptan NS at 10 minutes. In one trial, the rate of total symptom relief was significantly better with the NS than with placebo from 30 minutes post-dose. The most common side effect of zolmitriptan NS is unusual taste. Patient satisfaction studies indicate that zolmitriptan NS is appreciated for its speed of onset, ease of use, reliability, and overall efficacy. Conclusions.-Zolmitriptan NS provides onset of headache relief within 10 minutes for some patients and quickly abolishes some of the major migraine symptoms. Good candidates are migraineurs whose episodes rapidly escalate to moderate-to-severe pain and those who have morning migraine, have a quick time to vomiting, or have failed oral triptans. © 2013 American Headache Society. Source


Patent
Impax Laboratories | Date: 2015-12-04

The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.


Patent
Impax Laboratories | Date: 2012-02-06

The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.


Trademark
Impax Laboratories | Date: 2016-05-31

pharmaceutical preparations for the treatment of disorders of the central nervous system; pharmaceutical preparations and substances for the treatment of inflammation, musculoskeletal, respiratory, and immune system related diseases and disorders; pharmaceutical preparations for use in treating cancer; pharmaceutical preparations and substances for the treatment of infectious diseases, blood disorders, pain, sepsis, alopecia, obesity and cognitive disorders; pharmaceutical preparations and substances for the treatment of viral, metabolic, endocrine, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, and psychiatric diseases and disorders; pharmaceutical preparations and substances for the treatment of damaged skin and tissue; pharmaceutical preparations and substances for the prevention, treatment and/or alleviation of rheumatoid arthritis and of all diseases and disorders related to rheumatoid arthritis; pharmaceutical preparations for the prevention and treatment of neurological diseases and disorders; pharmaceutical preparations for the prevention and treatment of neurodegenerative diseases and disorders; pharmaceutical preparations for the prevention and treatment of peripheral nervous system diseases and disorders.


News Article | October 31, 2014
Site: www.fiercebiotech.com

Impax Laboratories ($IPXL) is slashing its R&D payroll and moving away from early-stage research, a move designed to save cash in the midst of a costly transition. The California company is letting go of 42 R&D employees, about 25% of its research staff, in an effort to save about $8 million a year. From here on out, Impax's branded R&D efforts will focus on products in Phase II and above, the company said, jettisoning some nascent projects and homing in on assets with a clear path to market. "By leveraging our resources in this manner, we improve our R&D efficiency and effectiveness," CEO Fred Wilkinson said in a statement. "This change is also designed to ensure we are investing in internal projects and external opportunities that enhance our pipelines, support our growth and offer the greatest return on investment, with the goal to create value for patients, customers and shareholders." Leading Impax's pipeline is Rytary, a long-delayed investigational therapy for Parkinson's disease once partnered with GlaxoSmithKline ($GSK). After manufacturing issues spiked a 2013 attempt at FDA approval, Impax purportedly fixed its process problems on the way to another overture at the agency, now expecting a final yes or no by Jan. 9. Behind its lead candidate, the company is developing IPX239, a bupivacaine patch for nerve pain, and IPX203, another Parkinson's drug. Impax also has a portfolio of 46 in-development generics, 23 of which have pending FDA filings on the books. Related Articles: Impax whacks jobs to try to right itself after Rytary delays cost it GSK deal Impax gives it another go with a once-rejected Parkinson's drug Impax gets products, manufacturing with $700M deal for allergy-drug makers

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