Pain Therapeutics and King Pharmaceuticals Receive Special Protocol Assessment for Remoxy(TM) and Commence Pivotal Phase III
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., Feb. 16 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today announced that Remoxy has successfully completed a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). As a result, the companies are commencing a pivotal Phase III trial with Remoxy in 400 patients with severe chronic pain.
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. 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 III design for Remoxy,' said Nadav Friedmann, PhD, MD, 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.'
Special Protocol Assessment
A Special Protocol Assessment (SPA) from the FDA specifies the Phase III trial objective, design, clinical endpoints and analyses needed to support regulatory approval. These features are considered binding, i.e., the FDA will not later alter its perspective unless public health concerns unrecognized at the time of protocol assessment under this process are evident. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf .
Phase III Trial Details
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 U.S. 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. Patient accrual is expected to begin shortly and continue through year end 2006.
About Remoxy
Remoxy is an abuse-resistant version of long-acting oxycodone. Remoxy's sticky, high-viscosity mass resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol releases just a fraction of oxycodone compared to Oxycontin(R) at time points when abusers presumably expect to get high. These physical properties of Remoxy are intended to deter recreational abuse or accidental patient misuse of long-acting oxycodone. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy.
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Peter considers this a slam dunk.
Message 22173593
An SPA for Oxytrex is next, and maybe not as much a slam dunk, but looks promising from previous phases.
Jack |
