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Scientist Advertisement Drugs for alcoholism don't have to lead to sobriety Share This PageFebruary 12, 2015Drugs to treat alcoholism can gain approval by proving patients using them no longer drink heavily, FDA clarified Wednesday. The agency released draft guidelines for pharmaceutical companies wanting to develop alcoholism treatments that make clear that sobriety does not have to be the main goal.
Drugs to treat alcoholism can gain approval by proving patients using them no longer drink heavily, FDA clarified Wednesday. The agency released draft guidelines for pharmaceutical companies wanting to develop alcoholism treatments that make clear that sobriety does not 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.
Bloomberg (02/11/15) Edney, Anna
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