Pain Therapeutics, King Pharmaceuticals receive Special Protocol Assessment for Remoxy

By Elaine Rigoli

Tampa, Fla., Feb. 16 - Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. announced Thursday that Remoxy has successfully completed a Special Protocol Assessment with the Food and Drug Administration.

As a result, the companies will start a phase 3 trial with Remoxy in 400 patients with severe chronic pain.

A Special Protocol Assessment from the FDA specifies the phase 3 trial objective, design, clinical endpoints and analyses needed to support regulatory approval.

Remoxy, an investigational drug, is an abuse-resistant version of long-acting oxycodone, a strong opioid painkiller. Remoxy is intended to meet the needs of physicians who appropriately prescribe oxycodone and who seek to minimize risks of drug diversion, abuse or accidental patient misuse, according to a company news release.

Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-resistant opioids.

"We are delighted to have reached agreement with the FDA on a phase 3 design for Remoxy," said Nadav Friedmann, PhD, MD, chief medical and operating officer of Pain Therapeutics, in a company news release.

"We believe this pivotal trial features achievable endpoints, addresses patient drop-out issues and provides a clear path towards product approval."

Pain Therapeutics is based in South San Francisco, Calif. and is a biopharmaceutical company. King is a pharmaceutical company based in Bristol, Tenn.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.