BioCentury
ARTICLE | Clinical News

Troxyca ER oxycodone/naltrexone regulatory update

September 5, 2016 7:00 AM UTC

FDA approved an NDA from Pfizer for Troxyca ER oxycodone/naltrexone to manage pain severe enough to require daily, around-the-clock long-term opioid treatment for which alternative treatments are inadequate. The pharma plans to launch Troxyca ER in 1Q17 and is still determining the drug’s price. Troxyca ER is extended-release oxycodone, an opioid agonist, surrounding sequestered naltrexone, an opioid receptor antagonist.

In June, FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 9-6 to recommend the analgesic’s approval. 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 (see BioCentury, June 13). ...