By Kathleen Doheny
WebMD Health News
Reviewed by Brunilda Nazario, MD
Feb. 3, 2015 -- The FDA has approved the first drug in the U.S. to treat binge-eating disorder, Vyvanse. The agency says it might lessen the number of food binges for people with the condition.
Vyvanse is already approved to treat ADHD.
Binge-eating disorder affects 1% to 5% of the population, or millions of Americans, according to the National Eating Disorders Association. It can lead to or contribute to obesity.
Everyone overeats from time to time, but binge eating disorder is different. It involves regularly eating a lot of food in just a few hours -- even when you're not hungry. Afterward, you feel shame or guilt about it.
For more information, WebMD turned to the FDA, drug-maker Shire, and Russell Marx, MD, chief science officer of the National Eating Disorders Association.
What is Vyvanse?
Vyvanse is a central nervous system stimulant. It was approved in 2007 to treat ADHD in people 6 and older.
How does it work?
In the two large clinical trials done by Shire, researchers found the drug worked to lessen the number of binge-eating episodes.
It's not clear how the drug helps against eating binges, says Marx, who's also the associate medical director of the Eating Recovery Center in Denver.
What did the clinical trials find?
In two studies involving more than 700 people, the drug lessened the average number of binge days more than a placebo. In one study, the drug cut the average number of binge days per week from nearly five to less than one at the end of the 12-week study. Placebo pills lessened binge days from nearly five to more than two. The second study showed similar results, according to Shire.
In a clinical trial, half of those taking the 70-mg dose of Vyvanse stopped binge eating during the 4-week period studied, compared to 21% of those taking placebo, according to a report published in JAMA Psychiatry.
While those in the clinical trials on the drug lost weight, the FDA didn't approve the drug for that use, Marx says. Even so, that would be a welcome benefit for many, since he finds that about half of people with binge-eating problems are overweight or obese.
What about side effects?
''The most common side effects are dry mouth, sleeplessness, increased heart rate, a jittery feeling, and anxiety," Marx says. "CNS (central nervous system) stimulants can cause psychotic or manic symptoms," he says. Sudden death can happen in people who have existing heart problems or heart defects, so it's crucial to tell your doctor about any heart-related condition before taking the drug.
It can also cause problems with blood flow, with numb or cool fingers or toes.
Doctors should be cautious about prescribing the drug for anyone with a history of mania or seizures, Marx says. Seizures can happen mainly in people with a history of them. The drug might cause manic symptoms, such as delusional thinking or mania, even if someone has no prior history of mental illness, the FDA says.
How will it be used?
Marx says it might be used along with psychotherapy. Therapy is often the recommended treatment for binge-eating disorder, sometimes together with nutritional counseling.
An anti-seizure drug is also sometimes prescribed, as are antidepressants. While these other drugs might help for some people, "these other medications are used off-label [not specifically approved to treat binge-eating disorder], and so have not been shown to have the same level of safety and effectiveness [for it]," Marx says.
People taking Vyvanse should be aware of the potential for dependence or abuse with long-term use, he says. He advises those who want to stop using the drug to do so under a doctor's supervision.
What is the recommended dose?
The recommended starting dose for Vyvanse for moderate to severe binge-eating disorder is 30 milligrams, then increased to a dose of 50 mg to 70 mg, according to Gwen Fisher, a Shire U.S. spokesperson. In clinical trials, moderate to severe binge-eating disorder was defined as having at least three binge days a week for 2 weeks prior to the trial.
What will the cost be? Will insurance cover it?
A month's supply of the 50-mg tablet is about $230, according to online sellers.
Patient assistance programs are available for those who qualify, Fisher says. Insurance covers the drug when used for ADHD, but it's not yet known if it will be covered for binge eating.
SOURCES: Russell Marx, MD, chief science officer, National Eating Disorders Association; associate medical director, Eating Recovery Center, Denver. Gwen Fisher, spokesperson, Shire U.S. Press release, FDA. Press release, Shire U.S. JAMA Psychiatry, Jan. 14, 2015.
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