WASHINGTON — Drugmakers aiming to tackle alcoholism, a condition that affects 17 million Americans and is in need of pharmaceutical options, may have a smoother path to market under a U.S. proposal to guide their development.
Drugs to treat alcoholism can get to market by proving patients using them no longer drink heavily, the Food and Drug Administration clarified Wednesday. The agency released draft guidelines for pharmaceutical companies wanting to develop alcoholism treatments that make clear that sobriety doesn’t have to be the main goal.
“The abstinence-based endpoints have often been considered an unattainable threshold in the clinical trial setting, and may be considered a hindrance to clinical development for drugs to treat alcoholism,” said Eric Pahon, an FDA spokesman.
Clinical trials of the three drugs that are FDA-approved and sold for alcoholism focused on sobriety, and most required patients to be abstinent to start the studies, Pahon said. The National Institute on Alcohol Abuse and Alcoholism has said current medications are effective for some but that more treatments are needed for the broader population.
“While total abstinence from alcohol is desirable, reducing heavy drinking to within ‘low-risk’ daily limits presents an alternative goal in drug development so more treatments may be developed,” Pahon said.
Industry, researchers and addiction and recovery groups can comment on the proposal for 60 days.
The drugs sold for alcoholism are: naltrexone, which limits the release of pleasure-inducing dopamine caused by alcohol; acamprosate, which can be used by those who have quit drinking to stay sober; and disulfiram, known as Antabuse, which creates unpleasant side effects in people who drink.
Alcoholism is identified as continued drinking despite physical and psychosocial consequences, according to the FDA proposal. Ultimately, an alcoholism drug should improve those consequences, which can be done through sobriety or by eliminating heavy drinking, the agency said.
The NIAAA defines heavy drinking as days when a man consumes more than four standard drinks or a woman consumes more than three. A standard drink in the United States contains 14 grams of alcohol, which could be in the form of a shot of hard liquor, a 12-ounce bottle of beer or a 5-ounce glass of wine.
The NIAAA and XenoPort Inc. said in September they would start a clinical trial in the first half of this year on the Santa Clara, California, company’s restless-leg syndrome medicine Horizant as a treatment for alcohol use disorder.
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