May 28, 2009 / 9:43 PM / in 9 years

UPDATE 2-US: new opioids could come as risk plans developed

(Adds additional FDA comments, partner on Remoxy drug)

WASHINGTON, May 28 (Reuters) - New opioid painkiller drugs could be approved before U.S. regulators impose stronger safety measures on a broad group of the medicines, a U.S. health official said on Thursday.

“We do feel that we have a path forward that would allow the possibility for new products in this class to be approved before” the new risk management rules are finalized, said Dr. John Jenkins, director of the Food and Drug Administration’s Office of New Drugs.

Jenkins, speaking to reporters, said he could not comment on the status of any specific applications under review.

King Pharmaceuticals Inc KG.N is awaiting FDA decisions on two experimental long-acting painkillers, Remoxy and Embeda. King is a partner with Pain Therapeutics Inc (PTIE.O) on Remoxy.

The FDA announced in February it wanted manufacturers to take stronger measures to prevent misuse and abuse of long-acting and sustained-release opioids, a class of powerful, highly addictive narcotics prescribed to relieve chronic pain.

    Jenkins spoke after a two-day meeting where the FDA heard comments from manufacturers, patient groups, doctors and others about potential safeguards.

    Imposing new safety requirements “is a major undertaking that will take time” due in part to the large number of prescribers that might need training, Jenkins said. (Reporting by Lisa Richwine; Editing by Steve Orlofsky)

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