FDAnews
www.fdanews.com/articles/84689-pain-therapeutics-and-king-pharmaceuticals-get-special-protocol-assessment-for-remoxy

PAIN THERAPEUTICS AND KING PHARMACEUTICALS GET SPECIAL PROTOCOL ASSESSMENT FOR REMOXY

February 20, 2006

Pain Therapeutics and King Pharmaceuticals have announced that Remoxy has successfully completed a special protocol assessment with the 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.