Friday, February 13, 2015
Sobriety Does Not Have to be Main Goal of Alcoholism Treatments, FDA Says
February 12th, 2015/
Drugs to treat alcoholism would not have to lead to sobriety in order to be approved by the Food and Drug Administration (FDA), under a proposal by the agency. Instead, drug companies could gain approval for treatments if they prove patients using them no longer drink heavily.
The FDA released draft guidelines this week for drug companies interested in developing alcoholism treatments. “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,” FDA spokesman Eric Pahon told Bloomberg Business. “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.”
The proposal is open for comment by industry, researchers and addiction and recovery groups for 60 days, the article notes.
In 2013, researchers found the drug gabapentin, used to treat epilepsy and some types of pain, can help people with alcoholism quit drinking. The 12-week study of 150 alcohol-dependent participants found gabapentin decreased the number of days people drank heavily, and at least tripled the percentage of people who were able to stop drinking altogether, compared with those receiving a placebo. The drug also reduced alcohol craving and improved mood and sleep quality.
The researchers noted currently available treatments for alcohol dependence have limitations. Disulfiram (Antabuse) and naltrexone (ReVia, Vivitrol), are relatively ineffective against anxiety, depression, sleeplessness and other withdrawal symptoms, they said. The researchers noted acamprosate (Campral), a newer drug approved for alcoholism treatment, has not been shown to improve mood or sleep.