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news.Intellipharmaceutics International has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ("FDA") seeking authorization to market its abuse-deterrent oxycodone hydrochloride extended release tablets branded as Rexista in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
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Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The submission is supported by pivotal pharmacokinetic studies that demonstrated that Rexista is bioequivalent to OxyContin (oxycodone hydrochloride extended release).
The submission also includes a comprehensive array of abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of drug by oral, intra-nasal and intravenous pathways, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labelling" guidance published in April 2015.
The abuse-deterrent properties incorporated into Rexista are designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse via common routes of administration including: ingestion following chewing, licking or crushing; insufflation; inhalation; or injection.
If approved, Rexista may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused. The Company previously announced the results of a food effect study which showed that Rexista can be administered with or without a meal (i.e., no food effect), providing another point of differentiation from currently marketed oral oxycodone extended release products.
As previously announced the FDA, under the small business waiver provision of the Federal Food, Drug, and Cosmetics Act, granted the Company a waiver of the $1,187,100 application fee for Rexista.
Intellipharmaceutics CEO Dr. Isa Odidi said: “The NDA submission of Rexista represents a critical milestone and turning point for the Company. This is our first NDA submission and the first abuse-deterrent oxycodone product candidate we are aware of that not only resists common forms of abuse but provides a preventive tool that may flag early warning of abuse.
“We are excited about the prospect of Rexista, if approved, having a positive impact in addressing the opioid epidemic. We believe our suite of abuse-deterrent and overdose prevention technologies are best in class and we look forward to further expanding our development program for abuse-deterrent pain and other medications.
“The Company has identified potential manufacturing partners and is currently evaluating various manufacturing options for Rexista in the U.S. We look forward to working with the FDA during their review of our NDA submission."