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Durect files NDA for pain drug

DURECT has submitted a new drug application for Remoxy to the FDA. Remoxy, an investigational drug, is a long acting oral formulation of oxycodone intended to treat moderate to severe pain.

Based on Durect’s Oradur technology, Remoxy is designed to resist common methods of prescription drug misuse and abuse.

Remoxy is being developed by Pain Therapeutics under license from Durect, and Pain Therapeutics has, in turn, sublicensed the commercialization rights to the drug candidate to King Pharmaceuticals.

James Brown, president and CEO of Durect, said: “We designed our Oradur technology to enable the abuse resistant properties of drug candidates such as Remoxy which has the potential to be the first oxycodone on the market that deters common methods of abuse.”