Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted (9 to 6) in favor of approval of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for its proposed indication, “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling for the oral route (6 to 9). The FDA will take the Committees’ recommendations into consideration before taking action on the New Drug Application for ALO-02.
“Pfizer believes the ALO-02 data support approval with abuse-deterrent labeling and we look forward to ongoing discussions with the FDA,” said Ken Verburg, PhD, Chief Development Officer, Neuroscience and Pain, Pfizer Inc. “Abuse-deterrent opioids are an important part of a multi-faceted approach to help address the growing abuse epidemic.”