Mallinckrodt announces Phase 3 efficacy results for pain drug

theflyonthewall.com

Mallinckrodt reported data that investigational drug MNK-795 achieved the primary endpoint in a Phase 3 efficacy trial in the treatment of acute pain following a bunionectomy. In the study, MNK-795 showed statistically significant improvement in pain scores compared to placebo from baseline over 48 hours. The data is being presented at PAINWeek, a national conference on pain for frontline practitioners, which is being held in Las Vegas September 4-7. MNK-795 is an investigational, extended-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 July, the U.S. Food and Drug Administration accepted for filing the New Drug Application for MNK-795 and granted priority review. The Phase 3 study was part of an FDA application for a regulatory pathway relying, in part, on data from existing reference drugs. Mallinckrodt also conducted – and will present at PAINWeek – data from several trials, including the pharmacokinetics, abuse liability, bioavailability, dose proportionality, and tolerability of MNK-795.

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