Mallinckrodt NDA Granted Priority Review By FDA

(RTTNews) - Mallinckrodt (MNK) said the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application or NDA for MNK-795 and granted priority review.

MNK-795 is 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.

In the event of being 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 advanced Acuform drug delivery technology with tamper-resistant properties.

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