(Adds additional FDA comments, partner on Remoxy drug)
WASHINGTON May 28 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
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)