Mallinckrodt's MNK-795 Meets Primary Endpoint In Phase 3 Efficacy Trial

(RTTNews) - Specialty pharmaceutical company Mallinckrodt(MNK) Thursday said its investigational drug MNK-795 met primary endpoint in a Phase 3 efficacy trial in the treatment of acute pain following a bunionectomy. The study determined the efficacy and safety of MNK-795 in patients with moderate to severe acute pain, and the primary endpoint was summed pain intensity difference over 48 hours. The drug showed improvement in pain scores compared to placebo from baseline over 48 hours.

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 company said that the tablet was designed using technology with immediate and extended-release components and potentially tamper-resistant properties. MNK-795 also received priority review from the FDA in July.