Scientists are looking into the effects of a new pain killer that can be used during surgery but avoids the unpleasant side effects associated with opioids.
Two phase III trials will examine the safety and efficacy of the drug known as Exparel (Depobupivacaine) for post-operative analgesia, Pacira Pharmaceuticals has announced.
The trial results, as well as existing preclinical and clinical data, are expected to underpin a planned new drug application filing under US Food and Drug Administration regulations.
Exparel is a novel long-acting, sustained-release formulation of bupivacaine, a local anaesthetic widely used for treating post-operative pain.
The focus of the study will be surgical procedures where post-operative pain management is especially problematic and where the need for prolonged analgesia with a single intra-operative administration can provide a significant improvement in pain relief.
Pacira says the improved post-operative pain management and a reduction in opioid consumption means patients will experience better pain management and have fewer opioid-related side effects such as nausea and vomiting, and improved outcomes overall.
Exparel is produced using Pacira’s sustained-release DepoFoam technology. DepoFoam covers the drug in multivesicular liposomal particles, which allows for the release of the active ingredient over a length of time without altering the drug molecule.
Copyright Press Association 2009