Aratana Therapeutics Reports Positive Effectiveness Data from Pilot Field Study of Bupivacaine Extended-Release Injectable Suspension (AT-003)
AT-003 Demonstrates Greater Pain Control Over Time Compared to Placebo in Client-Owned Dogs
KANSAS CITY, Kan., Sept. 9, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals, today announced positive results from its pilot field study of its Bupivacaine Extended-Release Injectable Suspension (AT-003) for managing post-operative pain in cats and dogs following surgery. In the study, which enrolled 46 client-owned dogs, AT-003 demonstrated significantly greater pain control over time following knee surgery compared to placebo. Based on these results, Aratana anticipates discussing the design of the pivotal field effectiveness with the FDA in the coming weeks and continues to anticipate the first FDA approval in 2016.
Pain levels were assessed repeatedly for 72 hours following knee surgery using the Glasgow Composite Measure Pain Scale, short form (CMPS-SF), a well-accepted and reliable metric for measuring acute pain in dogs. The data show that treatment with AT-003 resulted in a statistically significant reduction in mean total pain scores over time compared to placebo (p<0.05).
Aratana also analyzed the data for "no pain intervention post-surgery". The percent of patients treated with AT-003 which did not require additional pain medication was statistically greater (p<0.05) compared to placebo at each 24-hour time interval (0-24h, 24-48h, 48-72h) for up to 72 hours after surgery.
Steven St. Peter, M.D., President and Chief Executive Officer, stated, "The positive results from this pilot field study of AT-003 are highly encouraging and enable us to move forward with our plans for a pivotal effectiveness study in dogs. As previously announced, our next step will be to discuss the design of the pivotal field trial with the FDA. We believe we remain on track for FDA approval of AT-003 for use in dogs in 2016. In addition, we expect to start a cat pilot lab study in the fourth quarter 2014, potentially expanding the companion animal market for this exciting product, which is already approved and commercially available for use in humans in the United States."
Ernst Heinen, D.V.M., Ph.D., Chief Development Officer, stated, "At Aratana, we generally first conduct pilot lab and field studies then, when indicated, move into pivotal studies. We invest in pilot studies so that we can assess the statistical power and understand the endpoints, which we believe de-risks our drug development. This has been our approach since inception. Our confidence in our six lead programs is greatly enhanced by such pilot studies."
AT-003 was licensed from Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX).
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 more than fifteen 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.