FDA Advisory Committee recommends approval for ALO 02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release) to manage severe pain.- Pfizer

Pfizer Inc. announced that the 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.

Comment: The misuse of prescription opioids remains a serious and persistent issue in the US. According to the American Society of Addiction Medicine, 1.9 million people in the country had a substance use disorder involving prescription pain relievers in 2014, and four in five new heroin users started out misusing prescription painkillers. ALO-02 is intended to address this problem and uses technology which should discourage tampering associated with prescription opioid misuse and abuse.