Mallinckrodt's MNK-155 Shows Promise In Phase III Acute Pain Trial
By Cyndi Root
Mallinckrodt announced in a press release that a Phase III trial for MNK-155 met its primary endpoint. The oral formulation of hydrocodone and acetaminophen demonstrated improved pain scores compared to placebo in patients undergoing a bunionectomy. Mallinckrodt is presenting the data at PAINWeek 2014, a national pain conference held in Las Vegas, Nevada. The company’s New Drug Application (NDA) for MNK-155 submitted to the Food and Drug Administration (FDA) in May 2014, included data from the trial.
Dr. Mario Saltarelli, CSO, Mallinckrodt Pharmaceuticals, said, “In this study, MNK-155 showed rapid, significant and superior pain relief to placebo with a 12-hour dosing interval throughout the 48-hour study period. These positive Phase 3 findings are great news as we strive to develop new medications with less frequent dosing for patients with acute pain.”
MNK-155
MNK-155 (hydrocodone bitartrate/acetaminophen) is a reformulation of analgesic products. The drug, which is taken orally, is formulated with intermediate-and extended-release components and with abuse-deterrent characteristics. MNK-155 is engineered from the patented Depomed Acuform drug-delivery technology. Mallinckrodt licensed the Acuform platform in 2009. The polymer-based technology optimizes drug delivery, allowing targeted delivery of the therapeutic to the upper gastrointestinal (GI) tract. The polymers swell in the tract so the drug is retained for eight to 10 hours, unlike other formulations that are retained for about three hours. The extended release offers increased treatment tolerability and efficacy.
MNK-155 Phase III Study
The MNK-155 Phase III study was a multicenter, placebo-controlled trial, which compared safety and efficacy in 403 patients with moderate to moderately severe acute pain following bunion surgery. Subjects received a single dose of MNK-155 (7.5 mg hydrocodone/325 mg acetaminophen), followed by two tablets (15 mg hydrocodone /650 mg acetaminophen), each taken every 12 hours over 48 hours. Ibuprofen, up to 400 mg every 4 hours, was allowed in the MNK-155 group and the placebo group. The study’s primary endpoint was the change in pain from baseline (summed pain intensity difference) over 48 hours, which was statistically significant in favor of MNK-155. Adverse events included nausea, dizziness, vomiting, headaches, constipation, and sleepiness.
About Mallinckrodt
Mallinckrodt is a specialty pharmaceutical company operating worldwide in 65 countries. Focus areas include analgesics, central nervous system drugs, and autoimmune disorders. The company’s products include active pharmaceutical ingredients, generic drugs, and branded drugs.