FDA panel backs Troxyca efficacy, two abuse claims

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 9-6 to recommend approval of Troxyca ER oxycodone/ naltrexone ( ALO-02) from Pfizer Inc. (NYSE:PFE) to treat pain severe enough to require daily, around-the-clock long-term opioid treatment for which alternative treatments are not available. The committees voted 11-4 in favor of labeling the product as abuse deterrent by nasal routes and 9-6 by IV administration. They voted 9-6 against labeling it as abuse deterrent via the oral route.

Troxyca is an extended-release oxycodone, an opioid agonist, surrounding sequestered naltrexone, an opioid receptor antagonist. ...