FDA to review abuse-deterrent Pfizer opioid ALO-02

Pfizer said on Friday that the U.S. Food and Drug Administration has agreed to review the New Drug Application (NDA) for ALO-02, an abuse-deterrent opioid for chronic pain.

The opioid is for the management of pain severe enough to need daily, long-term opioid treatment and for which there is no other option for treatment. ALO-02 is an oxycodone variant designed to reduce abuse using oral, intranasal and intravenous routes when crushed. The ALO-02 capsule contain pellets that when crushed release naltrexone, which is designed to counteract the addiction effects of oxycodone.

Pfizer’s NDA submission to the FDA was based on findings from two phase 3 trials in patients with moderate-to-severe, non-cancerous chronic pain. Pfizer also conducted three studies in recreational opioid users and compared the potential for abuse of oral immediate release oxycodone with crushed ALO-02 when taken via oral, intravenous or intranasal means.

Prescription opioids are important treatments for individuals with chronic pain, but the misuse of opioids has been a serious problem in the past decade, especially oxycodone and Vicodin. The 2013 National Survey on Drug Use and Health said that approximately 10 million adults in the U.S. reported using prescription pain relievers for nonmedical use in 2012.

Pfizer said abuse-deterrent opioids are a vital step toward helping to address the issue of opioid abuse in the U.S.