FDA approves Apadaz for the short-term (no more than 14 days) management of acute pain.- KemPharm.
KemPharm, Inc.has announced that the FDA approved its New Drug Application (NDA) for Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate release (IR) combination of KemPharm�s prodrug, benzhydrocodone, and acetaminophen (APAP).
Comment: Apadaz is designed to deter certain common methods of abuse and has shown the potential to limit excessive opioid exposure in patients and non-medical users compared to Norco, which together with Vicodin, Lortab and other currently available hydrocodone combination products are among the most prescribed and the most widely abused (non-medical use) medications in the United States.
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