A drug being studied for the treatment of osteoarthritis pain in dogs showed positive results in a pivotal field study, according to the developer, Aratana Therapeutics Inc.
The Kansas City, Kan., veterinary drug maker also announced the launch of a pivotal field effectiveness study for a drug formulated to treat post-surgical pain in dogs.
The osteoarthritis drug, code-named AT-001, was used in a blinded, placebo-controlled, multicenter dose-ranging study involving 280 client-owned dogs. The dogs, all of whom had osteoarthritis, were split into AT-001 and placebo groups and received daily oral doses for 28 days, Aratana reported Thursday.
Validated owner-assessed pain scores showed that AT-001, which uses the compound grapiprant to target the EP4 receptor, demonstrated statistically significant improvements compared with the placebo, Aratana noted.
The company expects to win U.S. Food and Drug Administration approval of AT-001 in 2016.
“We believe AT-001 has the potential to be an important product in the well-established pain market,” said President and CEO Steven St. Peter, MD.
Aratana also reported the initiation of a pivotal field effectiveness study of a drug licensed from Pacira Pharmaceuticals Inc. of Parsippany, N.J. AT-003 is an injectable, extended-release bupivacaine formulated for post-operative pain in dogs.
A completed pilot study showed positive results. The new study will be a randomized, blinded, multicenter process involving 150 client-owned dogs undergoing knee surgery who will receive either AT-003 or a placebo.
“Knee surgery is common in dogs and represents one of the most prevalent claims of pet health insurance,” said Ernst Heinen, DVM, Ph.D., the chief development officer at Aratana. “AT-003 represents a truly differentiated treatment approach for managing post-surgical pain.”
If the new study proves AT-003’s effectiveness, the company hopes to receive FDA approval of the drug in 2016.