Oct. 1, 2013

Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Oxycodone/Acetaminophen Extended-Release (OC/APAP ER) Tablets in an Acute Pain Model.


Despite the wide range of treatment options available for acute pain, advances in the management of acute pain are needed.

Multimodal therapy combining oxycodone (OC) and acetaminophen (APAP) is a well-established approach to the treatment of acute pain. Combining agents with different mechanisms of action may offer additive effects, while allowing for the management of pain at a lower dose of each component, potentially reducing the risk of concentration-dependent adverse events.

In addition, formulations engineered to provide quick and sustained release may offer therapeutic benefit as well as reduce the pill burden

MNK-795 (OC/APAP ER) is an extended-release (ER) combination OC/APAP analgesic, and is being designed to provide both fast onset of analgesia within 1 hour and
sustained analgesia over the 12-hour dosing interval OC/APAP ER tablets employ a dual-layer biphasic delivery mechanism that, when administered as a single dose (ie, 2 tablets), ensures the immediate-release component delivers 3.75 mg OC/325 mg APAP and the ER component delivers 11.25 mg OC/325 mg APAP Incorporates technology designed to provide tamper resistance and abuse deterrence

In this pivotal clinical trial, OC/APAP ER was studied in an established acute pain model in patients undergoing a first metatarsal bunionectomy; medication effects were evaluated 48 hours post-procedure (double-blind) and continued throughout a voluntary open-label treatment period (up to 14 days)

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