Sep. 1, 2013

Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model

Immediate-release (IR) oxycodone (OC) provides analgesia within an hour after administration; however, dosing every 4 to 6 hours is required to maintain analgesia over time.

Oxycodone, an opioid analgesic, is commonly used in combination with acetaminophen (APAP) to manage moderate to severe acute pain. The effects of treatment with combination therapy (eg, opioids combined with the centrally acting nonopioid analgesic APAP) are thought to be at least additive and may allow for the management of pain at a lower dose of each component, potentially reducing the risk of concentration-dependent adverse events.

Formulations engineered to provide quick and sustained release may offer therapeutic benefit as well as reduce the pill burden MNK-795 (CR OC/APAP) is a controlled-release (CR) 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 CR OC/APAP tablets employ a dual-layer biphasic delivery mechanism that, when administered as a single dose (ie, 2 tablets), ensures the IR component delivers 3.75 mg OC/325 mg APAP and the extended-release component delivers 11.25 mg OC/325 mg APAP Incorporates technology designed to provide tamper resistance and abuse deterrence.
In this pivotal clinical trial, CR OC/APAP was studied in an acute pain model in patients undergoing a first metatarsal bunionectomy.

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