MNK 795 success in Phase III study for Acute Pain

Mallinckrodt has reported data that its investigational drug MNK-795 achieved the primary endpoint in a Phase III 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, 2013.

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. The tablet was designed using technology with immediate and extended-release components and potentially tamper-resistant properties.

In July 2013, the FDA accepted for filing the New Drug Application for MNK-795 and granted priority review.

The Phase III study was part of a 505 (b)(2) application, which is a regulatory pathway relying, in part, on data from existing reference drugs. Mallinckrodt examined patients in the bunionectomy setting, as it is a standard outpatient surgery in the Acute Pain space and a relevant efficacy study for this regulatory pathway.