King, Acura Fail to Win U.S. Panel's Backing for Experimental Painkiller

King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc. failed to win a U.S. panel’s backing to sell an experimental painkiller, sending Acura shares down about 45 percent in extended trading.

Data submitted by the companies don’t show the abuse- deterrent properties of the drug, Acurox, are effective enough to support its approval, outside advisers to the Food and Drug Administration said in a 19-1 vote today in Gaithersburg, Maryland. The FDA usually follows the recommendations of its advisory panels, though it isn’t required to do so.

King partnered with Acura to help develop Acurox, a short- acting tablet for moderate to severe pain that combines the narcotic oxycodone and niacin. Adding niacin, a B vitamin, is intended to cause unpleasant skin flushing in people who swallow too many of the tablets. The medicine also has properties to prevent crushing, melting or snorting for a quick high.

“What I’m hearing from the committee is that it’s probably not appropriate to put the niacin in this product because it does not have a definitive advantage, and it has associated side effects,” Jeffrey Kirsch, chairman of the Anesthetic and Life Support Drugs Advisory Committee, said before the vote. Kirsch also is chairman of the anesthesiology department at Oregon Health & Science University in Portland.

Revenue Estimates

Acurox would be the first immediate-release painkiller formulated to prevent abuse. If approved, the drug may generate $58.3 million in sales for Bristol, Tennessee-based King in 2012, or 3.2 percent of the company’s total revenue, according to the average estimate of seven analysts surveyed by Bloomberg. King licensed the drug from Palatine, Illinois-based Acura in October 2007 and has since expanded the partnership to include three other painkillers made from Acura’s Aversion technology designed to prevent abuse.

King fell 32 cents, or 2.8 percent, to $11.10 at 4 p.m. in New York Stock Exchange composite trading. The company has declined 9.5 percent this year. Acura dropped $2.63, or 45 percent, to $3.27 in extended trading after the close of the Nasdaq Stock Market. Trading on the company’s shares had been halted during the panel meeting.

“Obviously I’m disappointed by the results, but they didn’t tell us, ‘bad science, bad concept, bad idea,’” Eric Carter, King’s chief science officer, said after the vote. “They’ve given us an opportunity to go back and work with the FDA and to, as expeditiously as we can, come up with another solution.”

Asked whether that solution might be to remove niacin from Acurox, Carter said “everything is on the table.”

Niacin Questioned

FDA officials told the panel they agreed with the companies that Acurox is effective in preventing abuse by snorting or injection. Data submitted by the companies don’t show that niacin would be effective in deterring people from swallowing too many of the pills, in part because food and aspirin can weaken its flushing effect on the skin, they said.

“I wish that the product didn’t have niacin,” Maria Suarez-Almazor, a panel member who opposed approval, said after the vote. Suarez-Almazor is a professor of internal medicine at the University of Texas M.D. Anderson Cancer Center in Houston.

Almost 10 percent of U.S. high school seniors said they had used Vicodin, a short-acting painkiller, in the past year, according to a 2009 study, Monitoring the Future, sponsored by the National Institute on Drug Abuse.

Several Delays

Acura submitted a new drug application for Acurox with the FDA on Dec. 30, 2008, and the agency asked for more information about the potential abuse-deterrent benefits of the medicine six months later. The meeting today followed a Sept. 2 discussion with the agency in which King and Acura agreed to present their studies to an advisory panel.

Today’s session was a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

King won FDA approval in August to sell a tamper-resistant form of long-acting morphine called Embeda, developed by Alpharma Inc., which King acquired.

King also is developing a tamper-resistant long-acting form of oxycodone called Remoxy with Pain Therapeutics Inc. of San Mateo, California. The product would compete with a new form of OxyContin that the FDA approved this month for sale by Purdue Pharma LP, a closely held drugmaker from Stamford, Connecticut.

To contact the reporter on this story: Molly Peterson in Gaithersburg, Maryland at mpeterson9@bloomberg.net

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