Mallinckrodt Pharmaceuticals Announces Positive Phase 3 Efficacy Results for MNK-795, an Extended-Release Oxycodone/Acetaminophen Combination
Mallinckrodt (NYSE: MNK) today 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, 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, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for MNK-795 and granted priority review.
"Mallinckrodt is dedicated to developing and providing safe and effective medications for the treatment of patients with pain, and we believe these data represent an important milestone toward this commitment,' said Tom Smith, MD, Chief Medical Officer at Mallinckrodt. "We are pleased that MNK-795 met the primary endpoint of the study and we are excited to be able to share the clinical story for this product by presenting these and other data at PAINWeek.'
The Phase 3 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.
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.
The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose clinical trial comparing MNK-795 with placebo in 329 patients with acute pain following a unilateral first metatarsal bunionectomy. Subjects received either a fixed-dose of study medication (MNK-795, 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen tablets) of 2 tablets every 12 hours over 48 hours, or placebo. Supplemental ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-795 and placebo arms. 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 study evaluated the efficacy and safety of MNK-795 in patients with moderate to severe acute pain. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48). The most common adverse events associated with the use of MNK-795 were nausea, dizziness, headache, vomiting, constipation, and somnolence (sleepiness).