Complete Response Letter for Apadaz (benzhydrocodone and acetaminophen)for acute pain- KemPharm

KemPharm, Inc.has announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Apadaz (benzhydrocodone and acetaminophen), KemPharm�s investigational abuse-deterrent product candidate for the short-term management of acute pain. The FDA issues CRLs to indicate that the Agency considers the review cycle for an application is complete and that the application is not ready for approval in its present form. Included in the CRL is guidance that describes all specific deficiencies that the FDA has identified in the application. When possible, the FDA recommends actions that the applicant may take to place the application in condition for approval.

By 16 to 4, the panelists concluded that the opioid Apadaz, a prodrug of hydrocodone and benzoic acid combined with acetaminophen, should get an approval. But by 18 to 2 the panelists rejected a question added at the 11th hour, concluding that the drug should not be labeled as abuse deterrent.