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UPDATE 2-US FDA panel rejects King, Acura painkiller
* Panel urges FDA to reject Acurox in 19-1 vote
* King shares close down 2.8 pct, Acura shares halted
* Companies say will work with FDA on future steps (Adds panel member, company, analyst comments)
By Lisa Richwine
GAITHERSBURG, Md., April 22 (Reuters) - U.S. government advisers urged regulators on Thursday to reject an experimental painkiller from King Pharmaceuticals KG.N and Acura Pharmaceuticals (ACUR.O).
The Acurox pill was designed to discourage abuse, a major problem with prescription painkillers. The companies said people who took multiple pills at once would get high doses of niacin that could cause uncomfortable flushing.
Members of a Food and Drug Administration advisory panel praised the companies for trying to thwart abusers but said data did not show niacin would be a strong deterrent.
The drugmakers "haven't given us enough evidence that there is an incremental benefit," said panel chairman Jeffrey Kirsch, head of anesthesiology and peri-operative medicine at Oregon Health and Science University.
Taking Acurox with food, aspirin or other over-the-counter pain relievers seemed "sufficient to reduce the deterrent effect of niacin to make it no longer clinically relevant," Kirsch said.
The FDA had told the company in July 2009 that the agency would not approve the drug but agreed to seek input from the advisory panel, a group of outside experts.
King shares closed down 2.8 percent at $11.10 on the New York Stock Exchange on Thursday. Acura shares were halted on the Nasdaq while the panel met.
Some analysts had estimated peak sales for Acurox could hit $100 million a year. It would be Acura's first approved product if it reaches the market.
The drug is less important for King, which launched another abuse-resistant painkiller called Embeda last year and is developing others.
"This is only an incremental negative for (King) since Street expectations for the drug and its approval were low," Collins Stewart analyst Louise Chen said in a research note.
Any weakness in King's shares from the panel vote would be "a good buying opportunity," she said.
Officials from King told the panel Acurox was a step forward in efforts to prevent abuse of opioid painkillers, a major public health problem that the FDA has encouraged companies to address. U.S. government statistics show more than 13,000 fatal overdoses involving opioids occur each year.
In addition to niacin, Acurox includes an ingredient to cause burning in the nose if snorted. It also turns to a gel if added to water to discourage injection.
Panelist John Farrar said he had concerns niacin would do more harm than good. Studies found some legitimate pain patients who took recommended doses also experienced flushing. But Farrar said he favored the two other abuse-deterrent properties.
"If you'd stopped there, I'd be all for it," said Farrar, a University of Pennsylvania statistician.
The painkilling ingredient in Acurox is a short-acting form of oxycodone. The companies are seeking approval to sell the drug for treating moderate to severe pain.
King officials acknowledged food could lessen niacin's negative effects but said for some patients the flushing, which can include warmth, redness, itching and tingling, was severe enough to discourage misuse.
In a joint statement issued after the meeting, King and Acura said they "will work with the FDA to determine the next steps for the Acurox development program."
King Chief Science Officer Eric Carter told reporters he was disappointed panelists voted against the drug but said "they liked the science, they liked the concept."
"They've given us the opportunity to go back and work with the FDA ... we're certainly going to be looking at a number of different options," Carter told reporters.
Dr. Bob Rappaport, head of the FDA division reviewing Acurox, said "if they come back with a different set of data we'll probably come back to the committee."
(Reporting by Lisa Richwine, editing by Matthew Lewis, Bernard Orr)
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