AllTranz Inc.

KY, United States

AllTranz Inc.

KY, United States
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Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 695.99K | Year: 2014

DESCRIPTION (provided by applicant): According to the National Survey of Drug Use and Health (NSDUH) of 2008, 7.2 million Americans are in need of treatment for Substance-Related Disorders (SRDs), and a large proportion of those need treatment for opiate pain reliever, heroin, and alcohol addiction. Naltrexone (NTX), an opioid antagonist, is currently used in oral tablet form to help maintain opioid addicts in a drug-free state. NTX is also FDA-approved for the treatment of alcohol dependence. Substantial clinical evidence exists for the benefits of NTX treatment in smoking cessation, especially in women. Very intriguing clinical trial data has also been observed in amphetamine-dependent individuals, which is especially important as methamphetamine dependence has no FDA-approved treatment options. Treatment with NTX in the 90's produced variable success rates in addicts; however, current clinical NTX therapy is being optimized based on human pharmacogenetic data. A 30-day depot injection of the drug has be


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 537.78K | Year: 2012

DESCRIPTION (provided by applicant): According to the National Survey of Drug Use and Health (NSDUH) of 2008, 7.2 million Americans are in need of treatment for Substance-Related Disorders (SRDs), and a large proportion of those need treatment for opiate pain reliever, heroin, and alcohol addiction. Naltrexone (NTX), an opioid antagonist, is currently used in oral tablet form to help maintain opioid addicts in a drug-free state. NTX is also FDA-approved for the treatment of alcohol dependence. Substantial clinical evidence exists for the benefits of NTX treatment in smoking cessation, especially in women. Very intriguing clinical trial data has also been observed in amphetamine-dependent individuals, which is especially important as methamphetamine dependence has no FDA-approved treatment options. Treatment with NTX in the 90's produced variable success rates in addicts; however, current clinical NTX therapy is being optimized based on human pharmacogenetic data. A 30-day depot injection of the drug has beenapproved for the treatment of opiate addiction and alcoholism; however, postmarketing reports of serious injection site reactions (cellulitis, abscess, and necrosis) have recently required patient warning updates. Transdermal delivery systems offer a number of improvements over other delivery systems. Patches do not require swallowing, eliminating oral side effects; nor do they require skin puncture by syringe needles, eliminating pain and patient visits to a physician. Permeation through the skin allows the drug to directly enter the systemic circulation and avoid the first pass effect, decreasing gastric side effects and liver damage effects in hepatocompromised drug abusers and alcoholics. Transdermal delivery of NTX is desirable for addicts and alcoholics in order to help reduce side effects associated with oral/depot injection therapies and improve compliance. NTX itself does not have the essential physicochemical properties that would allow a therapeutic dose of the drug to cross the human skin barrier. Microneedle-enhanced transdermal delivery is an efficient and painless method for increasing the skin permeation of many drugs, including NTX. Microneedle products are currently in late-stage clinical trials for vaccine development, but this proposed product would be the first microneedle delivery system for multiple day sustained release systemic treatment. We hypothesize that NTX in combination with microneedle treatment will provide a therapeutic transdermal delivery rate of NTX. The initial screeningof the prototype patch will be completed in a Yucatan miniature pig pharmacokinetic study to verify that the patch system developed in vitro performs well in vivo (dose ranging study). The final studies for this proposal will be a group of critical GLP dermatotoxicology studies in animals to assess skin irritation and sensitization potential of the final patches. This final data will be used to apply for an IND, so that a Phase I clinical trial may begin at the end of this project. We will create a marketable and safe drug that will significantly aid in the treatment of addiction. PUBLIC HEALTH RELEVANCE: According to the National Survey of Drug Use and Health (NSDUH) of 2008, 7.2 million Americans are in need of treatment for Substance-Related Disorders (SRDs), and a large proportion of those need treatment for opiate pain reliever and heroin addiction. Additionally, over 8.5% of the U.S. population and 75 million people worldwide meet the diagnostic criteria for alcohol use disorders (AUDs), with alcohol abuse being among the top three preventable public health problems in the U.S. and the world. The proposed preclinical translational research will accelerate testing of naltrexone delivered via a transdermal microneedle system to assess its benefitsas a lead candidate in the search for improved alcoholism, opiate, and other drug addiction pharmacotherapies.


Patent
AllTranz Inc. | Date: 2011-10-12

The present invention overcomes the problems associated with existing drug delivery systems by delivering cannabinoids transdermally. Preferably, the cannabinoids are delivered via an occlusive body (i.e., a patch) to alleviate harmful side effects and avoid gastrointestinal (first-pass) metabolism of the drug by the patient. A first aspect of the invention provides a method for relieving symptoms associated with illness or associated with the treatment of illness in a mammalian subject, comprising the steps of selecting at least one cannabinoid from the group consisting of cannabinol, cannabidiol, nabilone, levonantradol, ()-HU-210, (+)-HU-210, 11-hydroxy-^(9)-THC, ^(8)-THC-11-oic acid, CP 55,940, and R(+)-WIN 55,212-2, selecting at least one permeation enhancer from the group consisting of propylene glycol monolaurate, diethylene glycol monoethyl ether, an oleoyl macrogolglyceride, a caprylocaproyl macrogolglyceride, and an oleyl alcohol, and delivering the selected cannabinoid and permeation enhancer transdermally to treat an illness.


Described herein are microneedle drug delivery systems comprising a pharmaceutical compositions comprising pharmaceutically active agents (e.g., cannabidiol and prodrugs of cannabidiol) and microneedle arrays suitable for local and systemic delivery of the active agent to a mammal. Also described herein are methods of using a microneedle transdermal or topical drug delivery systems comprising pharmaceutical compositions, comprising cannabidiol and prodrugs of cannabidiol, and microneedle arrays in the treatment disease, including pancreatitis and pancreatic cancer.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 160.50K | Year: 2011

DESCRIPTION (provided by applicant): With over 8.5% of the U.S. population and 75 million people worldwide meeting the diagnostic criteria for alcohol use disorders (AUDs), alcohol abuse is among the top three preventable public health problems in the U.S.and the world. AUDs, commonly referred to as alcoholism, have a complex etiology where chronic alcohol associated neurodegeneration, withdrawal-related anxiety and persistent alcohol craving are predictive of high relapse and poor clinical outcomes. The treatment of AUDs would benefit from a pharmacological approach that could address these overlooked endpoints to improve clinical outcomes. However, of the three drugs currently FDA-approved for the treatment of excessive alcohol consumption, none address neurodegeneration, withdrawal or anxiety. Cannabidiol (CBD) is a drug that could improve these three syndromes. Transdermal drug delivery of cannabinoids is a viable alternative to oral dosing. Most of the cannabinoids are highly metabolized in the liver.The oral bioavailability of CBD is only about 6%, and very low plasma drug levels were detected in CBD oral dose clinical trials. It is highly possible that clinical trials of oral dose cannabinoids in patients have given inconsistent results because of apoor choice of drug dosage form. We hypothesize that a CBD transdermal dosage form can be developed, and that this dosage form could provide therapeutic levels of drug in a future clinical study with alcoholic patients. The long-term hypothesis of the overall project is that CBD will decrease withdrawal related anxiety and control alcohol craving, thereby decreasing high relapse susceptibility in alcoholics by modulating the endocannabinoid system. In the first step towards this goal, a proof of concept evaluation of CBD prodrugs delivered via transdermal microneedles will be conducted. CBD itself does not permeate the skin at a therapeutic rate, unless it is applied as a gel to a large skin surface area, as the area of transdermal application is directly proportional to the delivery rate. Prodrugs are chemically modified parent drugs that are more skin permeable than the parent, and once they cross the stratum corneum quickly separate back into the parent drug and prodrug moiety. AllTranz has preliminary data showing that CBD prodrugs alone do not improve skin permeation, unless the prodrugs are specifically designed for use with microneedles. Additionally, CBD delivery with microneedles alone is not significantly enhanced, as compared to optimized CBD prodrugs for microneedle delivery. Specifically we aim to synthesize prodrugs of CBD that will be very skin permeable in combination with a microneedle device. We then aim to assess their in vitro human skin permeation for optimum flux. In future studies we willdevelop the prototype product and apply for an IND and begin Phase I clinical trials in healthy controls and alcoholics. The future CBD transdermal system could also be tested in Phase II clinical trials for opiate addiction, analgesic effect, inflammation relief (arthritis), and nausea and vomiting treatment, as there is substantial preclinical/clinical data with CBD to justify therapeutic utility for these indications. PUBLIC HEALTH RELEVANCE: With over 8.5% of the U.S. population and 75 million people worldwide meeting the diagnostic criteria for alcohol use disorders (AUDs), alcohol abuse is among the top three preventable public health problems in the U.S. and the world. Currently approved pharmacological treatments in the treatment of alcoholism and other types of drug addiction are limited in that they do not address multiple aspects of addiction: craving, neurodegeneration, withdrawal and anxiety. The proposed preclinical research will accelerate testing of cannabidiol (CBD) in an appropriate delivery system to assess its potential benefits as a lead candidate in the search for novel alcoholism and other drug addiction pharmacotherapies. The future CBD transdermal system could also be tested in Phase II clinical trials for analgesic effect,inflammation relief, and nausea and vomiting treatment, as there is also substantial preclinical/clinical data with CBD to justify therapeutic utility for these indications.


Described herein are abuse-resistant multi-layer transdermal patches comprising opioids and opioid prodrugs having a barrier layer located between the layer containing opioid or opioid prodrug and a layer containing an opioid antagonist or opioid antagonist prodrug.


Described herein are opioid prodrugs, methods of making opioid agonist-antagonist prodrugs, compositions comprising opioid agonist-antagonist prodrugs, abuse-resistant formulations and dosage forms of opioid agonist-antagonist prodrugs, and methods of using opioid agonist-antagonist prodrugs.


Described herein is a method of transdermally administering one or more pharmaceutically active agents to a mammal The method comprises administering one or more active pharmaceutical agents to the skm of the subject, in conjunction with microneedles and one or more COX inhibitors, whereby the COX inhibitors facilitate the absorption of the active pharmaceutical agents by prolonging the pore opening created by the application of the microneedle


Described herein are opioid prodrugs, methods of making opioid prodrugs, formulations comprising opioid prodrugs, and methods of using opioid prodrugs. One embodiment described herein relates to the transdermal administration of a buprenorphine prodrug in an abuse-resistant formulation for treating and preventing diseases and/or disorders.


Described herein are prodrugs of the opioid buprenorphine, methods of making them, formulations comprising these prodrugs, and methods of using them. One embodiment described herein relates to the transdermal administration of a buprenorphine prodrug in an abuse-resistant formulation for treating and preventing diseases and/or disorders.

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