FDA grants priority review to Remoxy
US Food and Drug Administration has accepted the New Drug Application for Remoxy (oxycodone) and granted it priority review status.
Remoxy is being developed by Pain Therapeutics under license from fellow-US firm Durect, and the former has sublicensed the commercialization rights for the drug candidate to King Pharmaceuticals. Remoxy is an abuse-resistant, controlled-release oxycodone product for moderate-to-severe chronic pain.
"We are pleased that the NDA has been accepted and that Remoxy will receive Priority Review," said James Brown, chief executive of Durect. "The abuse of pain medications is a widespread problem in this country and addressing that issue is clearly in the public interest," he added.
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