F.D.A. Approves Hysingla, a Powerful Painkiller

By RONI CARYN RABIN

The Food and Drug Administration on Thursday approved a long-acting opioid painkiller that contains pure hydrocodone, which some addiction experts fear will be abused.

The new drug, Hysingla, and another drug approved earlier this year, Zohydro, contain pure hydrocodone, a narcotic, without the acetaminophen used in other opioids. But Hysingla is to be made available as an “abuse-deterrent” tablet that cannot easily be broken or crushed by addicts looking to snort or inject it.

Nearly half of the nation’s overdose deaths involved painkillers like hydrocodone and oxycodone, according to a 2010 study by the Centers for Disease Control and Prevention. More than 12 million people used prescription painkillers for nonmedical reasons that year, according to the study.

Prescription opioid abuse kills more adults annually than heroin and cocaine combined, and sends 420,000 Americans to emergency rooms every year, according to the C.D.C.

Hysingla, however, will not be not abuse-proof, said officials at the F.D.A. and the drug’s manufacturer, Purdue Pharma. Its extended-release formulation, a pill to be taken once every 24 hours by patients requiring round-the-clock pain relief, will contain as much as 120 milligrams of hydrocodone.

The F.D.A. warned that doses of 80 milligrams or more “should not be prescribed to people who have not previously taken an opioid medication,” but officials described the abuse-deterrent formulation as a step forward.

“For patients who benefit from hydrocodone alone for the treatment of pain severe enough to need an opioid, this offers the advantage of once-a-day dosing in a formulation that we expect will reduce abuse and misuse,” said Dr. Douglas Throckmorton, deputy center director for regulatory programs at the F.D.A.

An official with Purdue Pharma said concerns about prescription-painkiller deaths were what motivated the company to develop abuse-deterrent products.

The tablets are hard and difficult to crush, and when mixed with water or other fluids, they become a “gelatinous, gooey mass that doesn’t pull into a syringe easily,” said Dr. David Haddox, the company’s chief of health policy.

“This is coming on to a market that is currently flooded with products that do not have abuse-deterrent options,” added Raul Damas, the company’s spokesman.

Dr. Andrew Kolodny, the chief medical officer at Phoenix House, a group of nonprofit addiction-treatment centers, said he was disturbed by the drug’s approval and disappointed that the F.D.A. did not seek input from an advisory committee of experts.

Dr. Kolodny said that addicts knew how to break down abuse-deterrent products for oral use, and that the 120-milligram tablets were particularly dangerous because they “pack an enormous amount of hydrocodone.”

The F.D.A. approved Zohydro last year despite the recommendation of its own expert advisory committee, which had voted against approval.