Aratana Therapeutics Initiates Pivotal Study for AT-003
Product is being developed to treat post-surgical pain in dogs
KANSAS CITY, Kan., Dec. 16, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today announced the initiation of the pivotal field effectiveness study for AT-003, the company's innovative drug for treating post-surgical pain in dogs licensed from Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX). 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."
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company's pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets' medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
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SOURCE Aratana Therapeutics, Inc.