Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone HCl and naltrexone HCl) extended-release capsules, for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. ALO-02 is designed to reduce abuse via oral, intranasal, and IV routes when crushed.
The NDA submission is based on the results from two Phase 3 trials in patients with moderate-to-severe, non-cancer chronic pain. In addition, Pfizer conducted three abuse-potential studies in recreational opioid users, comparing the abuse potential of crushed ALO-02 with immediate-release oxycodone when taken by the oral, intranasal or intravenous (the combination of oxycodone and 12% naltrexone was used to simulate crushed ALO-02 in the IV study) routes.
For more information call (484) 865-5194 or visit Pfizer.com.