MNK-795 NDA Granted Priority Review for Pain

Mallinckrodt announced that the FDA has granted its New Drug Application (NDA) priority review for MNK-795, a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The submission is based on data from a comprehensive clinical trial program for MNK-795 that included 14 clinical studies with 1,281 patients. The studies evaluated pharmacokinetics, efficacy, safety and abuse liability.

If approved, MNK-795 would be a controlled-release oxycodone and acetaminophen combination medication that has immediate and extended release components. The dosage form was designed using Depomed’s Acuform drug delivery technology with tamper-resistant properties.

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