King and Pain Therapeutics commence pivotal Remoxy trial

A special protocol assessment (SPA) from the FDA specifies the phase III trial objective, design, clinical endpoints, and analyses needed to support regulatory approval.

Under the terms of the SPA for Remoxy one pivotal phase III trial is required to file a new drug application. The randomized, double-blinded, placebo-controlled, multi-center pivotal trial will enroll 400 patients with moderate-to-severe osteoarthritic pain in multiple US clinical sites.

Following a titration period, patients will be randomized to either Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is reduction in pain scores over three months compared to baseline.

Remoxy is an investigational abuse-resistant version of long-acting oxycodone, a strong opioid painkiller. The drug 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.

“We are delighted to have reached agreement with the FDA on a phase III design for Remoxy,” said Dr Nadav Friedmann, chief medical and operating officer of Pain Therapeutics. “We believe this pivotal trial features achievable endpoints, addresses patient drop-out issues and provides a clear path towards product approval.”