Mallinckrodt announced results of a Phase 3 efficacy trial of the investigational drug MNK-795 for the treatment of acute pain following a bunionectomy. MNK-795 is an investigational, extended-release oral formulation of oxycodone and acetaminophen. The dosage form was designed using Depomed’s Acuform drug delivery technology with tamper-resistant properties.
The Phase 3, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose, multicenter clinical trial evaluated the efficacy and safety of MNK-795 vs. placebo in 329 patients with moderate to severe acute pain following a unilateral first metatarsal bunionectomy.
Subjects received either a fixed-dose of 2 tablets of MNK-795 (7.5mg oxycodone hydrochloride and 325mg acetaminophen) every 12 hours over 48 hours, or placebo. Patients in both study arms were allowed to take supplemental ibuprofen up to 400mg every 4 hours. Pain intensity was recorded at 2, 4, 8, and 12 hours after each dose, with additional recordings at 15, 30, 45, 60, and 90 minutes after the first dose. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48).
MNK-795 achieved the primary endpoint, showing statistically significant improvement in pain scores compared to placebo from baseline over 48 hours.
In July, the FDA granted priority review to the New Drug Application (NDA) for MNK-795.