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FDA Committee Votes Against Approval of Abuse-Deterrent Opioid Formulation

REMOXY ER has been developed for long-term opioid use

A PPM Brief

Pain Therapeutics (Austin, TX) announced1 that an FDA panel has voted against the approval of its extended-release (ER) oxycodone capsules (REMOXY ER), an abuse-deterrent opioid formulation. A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 against the approval. The reported argument for the denial: the marketplace may not need another abuse-deterrent, ER oxycodone product. Comparators involved in the decision review included: OxyContin ER, Xtampza ER, or Roxicodone IR.

REMOXY ER has been in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. The abuse-deterrent formulation aims to provide 12 hours of steady pain relief when properly prescribed and used, and promises to divert misuse/abuse through its high viscosity, hydrophobic gel formulation, which cannot be cut, grated or divided into smaller sizes. The formulation also resists syringe-ability, injection, and rapid extraction in ingestible solvents, according to the company website.

Phase 3 clinical efficacy studies involved 2,400 subjects across 30 trials, with 9,000 unique data points generated from 11 lab studies. The assessment of REMOXY ER’s abuse deterrence is supported by data from FDA studies, according to a company release.

FDA has set a PDUFA target action date of August 7, 2018 for completion of its review of the NDA for REMOXY ER.

Last updated on: June 15, 2020
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Why Prescribers Need to Adopt Abuse-Deterrent Opioids
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