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Controlled-Release Oxycodone/Acetaminophen Combo Gets Priority Review Status

Indication sought for treatment of acute pain (July 29)

The FDA has accepted a new drug application (NDA) for MNK-795 (Depomed/Mallinckrodt), 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 FDA granted the NDA a priority review, a designation given to drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared with standard applications.

MNK-795 is a reformulation of existing controlled-substance analgesic combination products (oxycodone and acetaminophen) that may be indicated for moderate-to-severe acute pain. According to the compound’s developer (Mallinckrodt), MNK-795 was formulated as a low-dose product to meet an unmet clinical need in the market and also has certain abuse-deterrent characteristics.

Source: Depomed, Inc.; July 29, 2013.

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