Federal regulators want to spur creation of more drug treatments for alcoholism, which affects roughly 17 million Americans but for which a new medication hasn’t been put on the market in nearly a decade.
The Food and Drug Administration has proposed relaxing its guidelines to allow new medicines to be sold if the drug makers can prove their products reduce alcohol consumption. The current guidelines require the drug makers to prove their product leads to total sobriety.
The change would make it easier for manufacturers to demonstrate to the FDA that their products are effective.
Currently there are two types of drugs to treat alcoholism: The first makes people sick whenever they take a drink, and the second reduces alcohol cravings. The drugs are usually given to patients who are on therapy and in self-help programs.
The options for the two types are very sparse. There is only one drug that makes alcoholics sick — disulfiram, known by the brand name Antabuse, which has been on the market since the 1950s. There are three drugs that reduce cravings, with the last one called naltrexone (brand name Vivitrol) being approved in 2006.
The development of more treatments will give patients more options to find the one that works for them, said Dr. Raye Litten, associate director of the National Institute on Alcohol Abuse and Alcoholism’s Division of Treatment and Recovery Research.
Litten brought up the example of depression treatments. Patients have a multitude of antidepressants and can select the one that works best. That same menu of options is needed for alcoholism treatments, Litten told the Washington Examiner.
Before any drug is approved, the drug maker must conduct at least two clinical trials to prove to the FDA it is safe and effective. Currently the threshold for proving an alcoholism treatment is effective is whether the patient swears off alcohol altogether.
But the FDA acknowledged that was a very high bar for drug makers to meet. So the agency proposed a manufacturer must prove over a six-month clinical trial that its product either leads to abstinence or no heavy drinking, which is more than four drinks in a day for men and three for women.
The shift will give drug makers a better chance to identify patients helped by the product and garner more positive results.
Say that a patient’s craving is reduced but they have a drink during the clinical trial. “If abstinence was the only outcome measure, that patient would be seen as a failure,” Litten said.
The proposed threshold shouldn’t be used for patients who are severe alcoholics because they need to swear off alcohol altogether, said Dr. Harris Stratyner, a board member for the advocacy group National Council on Alcoholism and Drug Dependence.
However, he said that new treatments are desperately needed to treat alcoholism, which can affect other systems of the body such as the heart and stomach.
Statistics from the NIAAA said that approximately 17 million adults had an alcohol disorder in 2012. Alcohol has been a factor in 88,000 deaths a year in the U.S.
The FDA currently wants comments on the proposed guidelines, which were detailed in a draft regulatory guidance, within 60 days and then will make a final decision.
