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Mallinckrodt Inc. to Unveil First Clinical Data on MNK-795, an Extended-Release Oxycodone and Acetaminophen Combination, at PAINWeek


8/28/2013 10:56:42 AM

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ST. LOUIS--(BUSINESS WIRE)--Mallinckrodt (NYSE: MNK) announced today that the first clinical data on MNK-795 will be presented at PAINWeek 2013, to be held September 4-7 in Las Vegas. MNK-795 is an extended-release oral formulation of oxycodone and acetaminophen that has been studied in clinical trials for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. On July 29, Mallinckrodt announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for MNK-795 and granted priority review. The data to be presented include results from a human abuse liability (HAL) study comparing certain abuse-related characteristics of intact and tampered-with MNK-795 with that of intact and tampered-with Percocet®1 (an immediate-release oxycodone/acetaminophen formulation); single- and multi-dose pharmacokinetic studies that characterize the drug release profile with immediate- and extended- release components over the 12-hour dosing interval; and a study of the compound’s efficacy and safety in an acute pain model.

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