Oxycodone/naltrexone regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet on June 8 to discuss an NDA from Pfizer for ALO-02 to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is extended-release oxycodone -- an opioid agonist -- surrounding sequestered naltrexone -- an opioid receptor antagonist -- designed to reduce abuse via the oral, intranasal and IV routes when crushed. ...