Xanodyne has received approval from the FDA for Zipsor (diclofenac potassium) Liquid Filled Capsules, to treat mild-to-moderate acute pain in adults.
The recommended daily dose of diclofenac potassium delivered with Zipsor, aligns with current FDA guidance recommending utilization of NSAIDs at the lowest effective dose, for the shortest amount of time. Zipsor was generally well-tolerated and demonstrated efficacy in two multiple dose post-surgery (bunionectomy) clinical trials.
Gary Shangold, CMO of Xanodyne, said: “Zipsor is a drug with several unique features. It is the first NSAID to be approved based on the demonstration of safety and efficacy in two well controlled post-surgical bunionectomy clinical trials and accomplished this with the lowest available dose (25mg) of any currently marketed diclofenac potassium product in the US.”