On June 26th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee reviewed New Drug Application (NDA) 022324 for extended release oxycodone capsules (Remoxy ER) by Pain Therapeutics Inc.
Remoxy ER is an abuse deterrent, pain relief medication for those with severe enough pain to require constant, long term opioid treatment. According to the CDC, there were more than 64,000 opioid overdose deaths in 2016. Pain Therapeutics developed a new Abuse-Deterrent Formulation (ADF) for oxycodone ER capsules in an effort to combat the problem. Remoxy ER is intended to be taken once every 12 hours.
The sponsor indicated that Remoxy ER is produced with a high viscosity formulation that does not flow, making it difficult to snort, syringe or inject into one’s body. The sponsor also claimed that attempting to smoke this drug will release vapors that irritate the lungs and eyes, while the active ingredient degrades.
However, studies conducted by an independent lab did not support either case. An independent smoking study showed significantly more carbonized oxycodone with Remoxy ER that OxyContin ER. Overall, the drugs deterrent properties are supported by data from FDA Categories 1 through 3 studies.
The panels voted 14 to 3 against the approval of Remoxy ER. The agency is not obligated to follow its panel’s recommendation, but normally does so.
ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com
This post was authored by Sami Mourad. Sami is a summer intern at ISS and a 3rd year pharmacy student at the Rutgers University Ernest Mario School of Pharmacy.