Committees will discuss the drug's risk/benefit profile and whether it can safely deter abuse.
Advisory committees meet today to assess the new drug application (NDA) for Intellipharmaceutics Corp.’s oxycodone hydrochloride (Rexista) extended release oral tablets — an allegedly tamper-proof, abuse-deterrent painkiller that is bioequivalent to OxyContin.
The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committees will discuss the overall risk-benefit profile of the product, and whether Intellipharmaceutics has sufficiently demonstrated abuse-deterrent properties that could warrant relevant labeling.
“One potentially important step towards the goal of creating safer opioid analgesics has been the development of opioids that are formulated to deter abuse. FDA considers the development of these products a high public health priority,” an FDA meeting document read. “The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical and statistical methods for evaluating those technologies are rapidly evolving. Based on the nature of the field, FDA intends to take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.”
The drug has several features that make it more difficult and stigmatizing to abuse, according to Intellipharmaceutics. It was designed to:
In March 2015, Rexista successfully met the endpoint of a phase 1 trial in which it received bioequivalence criteria (90% confidence interval of 80% to 125%) for all three matrices of comparison.
Intellipharmaceutics filed the NDA for Rexista in November of 2016. In February 2017, the FDA accepted for filing the NDA seeking authorization to market the drug in 10, 15, 20, 30, 40, 60 and 80 mg doses.
If proven safe and effective, the drug could siphon some of OxyContin's massive sales, which totaled $2.1 billion last year alone.
The joint meeting of the FDA’s advisory committees will close at 5pm, July 26.