FDA Rejects Approval of Pain Drug Apadaz
KemPharm announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of Apadaz (benzhydrocodone and acetaminophen) for the treatment of moderate to moderately severe acute pain.
The FDA issues CRLs to inform companies that the review of the NDA has been completed but is not ready for approval in its present form. The CRL includes guidance describing all specific deficiencies identified in the NDA.
The Company is currently evaluating the letter and intends to plan a meeting with the FDA to determine the necessary steps to resolve the issues.
Apadaz, an investigational abuse-deterrent opioid analgesic, is an immediate release combination of benzhydrocodone HCl, a prodrug of hydrocodone and benzoic acid, and acetaminophen. It utilizes KemPharm's Ligand Activated Therapy (LAT) platform technology and designed to release its hydrocodone component after being metabolized in the GI tract following oral administration.
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