Pfizer Announces FDA Acceptance for Review of NDA for ALO-02

Pfizer Inc.

announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid 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 an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed. Prescription opioids are an important treatment option for patients with chronic pain, but the misuse, abuse, and diversion of these agents remains a serious and persistent problem. In 2013, according to the National Survey on Drug Use and Health, nearly 10 million U.S. adults reported prescription pain reliever use for non-medical purposes in the previous year1. Abuse deterrent opioid medications incorporate technology designed to make the product difficult to abuse, yet when used appropriately, provide patients with intended pain relief. Pfizer believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the U.S. Pfizer supports the appropriate use of opioid pain medications and is committed to research in this field. If approved, ALO-02 would become Pfizer's second abuse deterrent formulation opioid. Pfizer's submission to the FDA is based on the results of 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.