Aratana Reports Positive Results from Pivotal Field Study of AT-001
Aratana is pleased to announce positive results from its pivotal field study of AT-001 (Grapiprant), the company’s innovative drug for treating pain in dogs with osteoarthritis. In the study, dogs receiving AT-001 demonstrated improvements in pain assessment scores that were statistically significant compared to placebo (p<0.05) at a once-daily oral dose. Aratana expects to commence commercialization upon FDA approval, which Aratana anticipates in 2016.
The blinded, placebo-controlled, multi-center dose-ranging study of AT-001 enrolled 280 client-owned dogs with osteoarthritis. Dogs were randomized equally into one group treated with AT-001 and one group treated with placebo. Dogs were dosed for 28 days, and effectiveness was determined by a standard protocol utilizing a validated owner-assessed pain score.
Ernst Heinen, DVM, Ph.D., Head of Drug Evaluation and Development for Aratana Therapeutics, stated, “We are very pleased with these results, which gives us confidence in moving forward towards approval of this novel drug.”
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, added, “We believe AT-001 has the potential to be an important product in the well-established pain market. We look forward to continuing our dialogue with the FDA’s Center for Veterinary Medicine regarding the AT-001 program.”
Aratana will discuss these results in more detail when the final study reports are available.