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FDA Urges Studies on Safer Formulations of Narcotic Painkillers
Date:1/10/2013

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Jan. 9 (HealthDay News) -- As part of an effort to control the misuse of prescription narcotic painkillers, the U.S. Food and Drug Administration is calling on drug makers to study formulations of the medications that would deter people from abusing them.

"Opioid drugs provide significant benefits for patients when used properly," Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said during an afternoon press conference Wednesday.

However, "opioids also carry a risk of abuse, misuse and death," he said. In 2009, there were nearly 425,000 emergency department visits involving inappropriate use of narcotic painkillers and an estimated 15,600 deaths involving these drugs, Throckmorton added.

The draft guidance the FDA issued Wednesday is designed to let drug makers know what kinds of studies to conduct to measure the effectiveness of the new formulations, and how the agency will evaluate safety claims pharmaceutical companies make about their product.

One issue yet to be dealt with is whether the makers of cheaper generic versions of narcotic painkillers will also be asked to try to produce tamper-free versions of their product.

"This guidance doesn't address generics," Throckmorton said. "What future action we might take with regards to generics in requiring they have abuse- deterrent technologies I simply can't comment on today."

Narcotic painkillers can be abused in many ways, including crushing pills to make them easier to dissolve and inject, the agency explained.

The FDA pointed out, however, that the science of abuse deterrence is relatively new, and ways of making drugs harder to abuse are quickly developing and changing.

If the new formulations meet the requirements for being deemed tamperproof, the drug maker could label its product as being safer, according to the agency.

"Our decision-making will be based on the scientific data that are submitted to us," Throckmorton said. "The FDA intends to take a flexible approach to the evaluation and labeling of these products as the new science evolves."

The FDA is looking for public comments on the draft guidance, and will make its final recommendations later in the year.

"Drug companies are looking at new ways to make it very hard to use a drug [in ways other] than what is intended," said Peter Delany, director of the Center for Behavioral Health Statistics and Quality at the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

It will take a combined effort from federal and state governments, doctors and other health care professionals to stop the misuse of these drugs, Delany said.

SAMHSA recently released a report that highlights the extent of the prescription-drug-abuse problem state by state. According to that report, some 22 million Americans abused prescription painkillers in 2002.

Pooled data from 2010 and 2011 shows the rates of prescription painkiller abuse for those aged 12 or older ranged from 3.6 percent in Iowa to 6.4 percent in Oregon.

More information

For more on prescription drug abuse, visit the U.S. National Library of Medicine.

SOURCES: Peter Delany, Ph.D., director, Center for Behavioral Health Statistics and Quality, U.S. Substance Abuse and Mental Health Services Administration; Jan. 9, 2013, press conference with Douglas Throckmorton, M.D., deputy director, regulatory programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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