Aratana Therapeutics Initiates Pivotal Study for AT-003
At Aratana, we are focused on delivering novel solutions for unmet and underserved medical needs in pets. To further this goal, we have initiated a pivotal field effectiveness study for AT-003, an innovative drug for treating post-surgical pain in dogs licensed from Pacira Pharmaceuticals, Inc. AT-003 is an extended release injectable formulation of bupivacaine.
The randomized, blinded, multicenter pivotal study will enroll approximately 150 client-owned dogs undergoing knee surgery and will be conducted under a study protocol for which Aratana received concurrence from the FDA’s Center for Veterinary Medicine (CVM). Dogs participating in the study will be given AT-003 or placebo. Efficacy endpoints will be based on pain evaluation at 24-hour intervals up to 72 hours after surgery, as indicated by the Glasgow Composite Measuring Scale, a well validated and widely used scoring system.
Ernst Heinen, D.V.M, Ph.D., Chief Development Officer of Aratana Therapeutics, stated, “Knee surgery is common in dogs and represents one of the most prevalent claims of pet health insurance. AT-003 represents a truly differentiated treatment approach for managing post-surgical pain. We look forward to reporting the pivotal study data, and if the results are favorable, beginning commercialization upon FDA approval, which we anticipate in 2016.”