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US opioid makers need plan to safeguard users-FDA

http://www.reuters.com/article/marketsNews/idINN0952768420090209?rpc=44

WASHINGTON, Feb 9 (Reuters) - U.S. makers of opioid painkillers will have to take stronger measures to prevent misuse and abuse of the addictive prescription drugs, the U.S. Food and Drug Administration said on Monday.

The FDA said it was concerned about rising numbers of overdoses and accidental deaths over the past decade despite steps to safeguard users.

Opioids are a class of powerful, highly addictive narcotics often prescribed to relieve chronic pain.

Johnson & Johnson (JNJ.N), King Pharmaceuticals Inc (KG.N), Endo Pharmaceuticals Holding Inc (ENDP.O) and privately held Purdue Pharma were among 16 manufacturers of brand name and generic opioids asked to implement extra safety measures.

Twenty-four drugs were specifically mentioned by the FDA, including J&J's Duragesic patch, Purdue's Oxycontin, King's Avinza and Endo's Opana.

Natixis Bleichroeder analyst Corey Davis said the move was unlikely to impact current sales as it could take a year or longer to devise a plan to apply to all of the manufacturers. But he said the effort could delay approval of King's two experimental painkillers, Remoxy and Embeda. Remoxy is being developed by Pain Therapeutics Inc (PTIE.O: Quote, Profile, Research, Stock Buzz) with King as a partner.

About 21 million prescriptions for the 24 targeted drugs were dispensed to about 3.7 million patients in 2007, Dr. John Jenkins, director of the FDA's Office of New Drugs, told reporters.

He said hundreds of deaths were reported each year from abuse or accidental overdose of opioids.

The FDA plans a public meeting on the issue in late spring or early summer, in addition to a March 3 meeting with the manufacturers.

Agency officials want to make sure the drugs are prescribed only by doctors trained in appropriate use without limiting access to legitimate pain sufferers, Jenkins said.

King said in a statement it would discuss the matter with the FDA and was "committed to responsible pain management and minimizing the risks of effective pain medicines."

The FDA has not told the company if the effort will affect the timing of the agency's review of Embeda, King said.

Endo Pharmaceuticals spokesman Blaine Davis said the company would meet with the FDA. "We recognize the importance of the initiative but also recognize the important need for patients to have access to the medicines," he said.

Greg Panico, a spokesman for Johnson & Johnson unit PriCara, said the company would work with the FDA on the effort.