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 (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 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)