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Pain and King Begin Remoxy Phase 3 Study

Posted on: Thursday, 16 February 2006, 12:00 CST

Pain Therapeutics and King said Thursday they are beginning phase 3 studies of their painkiller candidate Remoxy.

The companies also said Remoxy completed a special protocol assessment with the Food and Drug Administration.

We are delighted to have reached agreement with the FDA on a Phase 3 design for Remoxy, Nadav Friedmann, Pain Therapeutics' chief medical and operating officer, said in a statement. We believe this pivotal trial features achievable endpoints, addresses patient drop-out issues and provides a clear path towards product approval.

Remoxy is intended to be an abuse-resistant version of long-acting oxycodone. The companies said the compound's sticky, high-viscosity mass resists injection or snorting. In addition, freezing and crushing Remoxy releases only a fraction of oxycodone compared to Purdue Pharma's Oxycontin.

The phase 3 trial will involve 400 patients with moderate to severe osteoarthritic pain who will be randomized to receive either Remoxy or placebo for 12 weeks. Patient recruitment is expected to continue through the end of the year.

Source: United Press International

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