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Groups urge FDA to halt launch of Zohydro pain drug

By Susan Heavey

WASHINGTON (Reuters) - A coalition of addiction experts, physicians and others is urging U.S. health officials to reverse course and block the launch of a powerful painkiller called Zohydro, expected to hit the market next month.

The opioid drug, manufactured by Zogenix Inc, contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.

"Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child," they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.

In December, attorneys general from 28 states also urged the FDA to reconsider its approval of the drug.

Zogenix, in a statement, said it was confident in the FDA's approval of the drug, which will be "subject to stricter prescribing and dispensing rules." The company has said it plans to start selling the drug in early March.

The latest petition comes as the United States grapples with an epidemic of prescription drug abuse, especially involving powerful opioid pain medications. Opioids are a class of drugs that includes morphine, codeine and oxycodone as well as hydrocodone.

Nearly 5 million people in the United States ages 12 and older abuse pain drugs, outpacing sedatives, stimulants and other abused medications, according to a 2012 U.S. government survey.

The FDA, which has launched its own efforts aimed at curbing abuse of pain-killing medications, approved Zohydro last year despite earlier concerns from a panel of FDA outside advisers worried about addiction risks.

The FDA advisers echoed the concerns of public health experts, law enforcement and others, who pointed to the drug's delivery system and say they are worried about the potential for Zohydro to be crushed or injected.

Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc's Vicodin or UCB Inc's Lortab, advocates said in their petition.

"Zohydro is not safer," they wrote.

Both Vicodin and Lortab also contain the pain-killing ingredient acetaminophen. Zohydro does not.

FDA officials have said they are working to balance public health worries about opioid addiction with access to the drugs for patients seeking pain relief. The FDA has said Zohydro's benefits outweigh its risks.

FDA spokeswoman Morgan Liscinsky said the agency would review the group's letter.

The petition was signed by 42 supporters, including representatives of advocacy groups such as Public Citizen as well as physicians and community addiction treatment providers.

In October the FDA recommended tighter restrictions on products that contain hydrocodone, and on Thursday the Drug Enforcement Administration proposed a rule that would reclassify hydrocodone-containing products.

Until now, Vicodin and other products that contain less than 15 milligrams of hydrocodone have been classified as Schedule III controlled substances. The DEA proposes reclassifying them more restrictively, as Schedule II products, in line with opioids such as morphine and oxycodone.

Reclassifying the products would make them harder to obtain, both by addicts and by legitimate pain patients. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.

Last year an advisory committee to the FDA voted in favor of rescheduling the products. In December the Department of Health and Human Services sent the recommendation to the DEA.

Shares of San Diego-based Zogenix closed down about 2.6 percent at $4.56 on the Nasdaq.

(Reporting by Susan Heavey; Editing by Jeffrey Benkoe and David Gregorio)

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