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.