UPDATE 3-U.S. FDA staff questions King, Acura pain drug

Tue Apr 20, 2010 5:27pm EDT

* Agency cites concerns with niacin added to pain drug

* FDA advisory panel to give input on Thursday

* Acura shares fall 21 percent (Adds analyst comment)

By Lisa Richwine

WASHINGTON, April 20 (Reuters) - U.S. regulators questioned if an experimental pain drug from King Pharmaceuticals KG.N and Acura Pharmaceuticals (ACUR.O) would deter abuse, documents released on Tuesday showed.

Shares of Acura, which is aiming to win approval for its first product, fell 21 percent to $6.23 on the Nasdaq.

Acurox pairs an immediate-release form of the opioid painkiller oxycodone with niacin, a B vitamin. Adding niacin was meant to discourage people from taking multiple pills at once as high niacin doses can cause uncomfortable flushing.

Food and Drug Administration staff, in a summary prepared for an advisory panel, said "while the oxycodone component in Acurox is efficacious, the agency has concerns about the use of niacin."

An Acura study suggested "niacin offers little in the way of deterrence to oral abuse," the summary said. Studies showed niacin's negative effects could be reduced by taking it with food.

Adding niacin also "appears to negatively affect the adverse event profile of this drug," the FDA staff said, noting higher reports of flushing in pain patients treated in Acurox compared with a placebo.

The FDA will ask an advisory panel for input on the drug at a public meeting on Thursday.

A key question will be if flushing is an acceptable risk for legitimate patients with pain, according to a separate memo prepared for the panel.

The agency also will ask the committee of outside experts about the ability of food and over-the-counter pain medicines to reduce flushing.

"These are clearly difficult questions for which there are no easy answers," wrote Dr. Bob Rappaport, director of the FDA division that is reviewing Acurox.

Lazard Capital Markets analyst Bill Tanner said the drug had a 50 percent chance of winning the advisory panel's support.

"You could see where they could say this doesn't really bring anything to the party," Tanner said. But he added that the fact that "opioid abuse is a massive massive healthcare problem" could work in the drug's favor as it appeared safe and the panel may see some benefits.

Acura, in a separate summary prepared for the panel, said the drug would limit misuse without "without incurring an incremental safety penalty." In addition to niacin, the drug includes ingredients designed to cause burning in the nose if an abuser crushes and snorts it. The drug also turns to a gel if added to water or another solvent to discourage injection.

"It is not a perfect solution to the opioid abuse crisis, but it is a solution that warrants approval of the product," the company said in the summary.

Acura Chief Financial Officer Peter Clemens said in an interview that some patients in the company's late-stage studies of Acura felt minor effects of niacin. But he said none of the effects were severe or caused patients to drop out of the studies.

The FDA usually follows panel recommendations when deciding whether to clear new products for sale.

Analyst Tanner said King investors had "very low" expectations for approval of Acurox so an endorsement would be a "nice positive surprise." Tanner said he estimated peak sales of about $100 million for the drug if it reaches the market.

King shares gained 8 cents to close at $11.50 on the New York Stock Exchange. (Reporting by Lisa Richwine, editing by Gerald E. McCormick and Matthew Lewis)