First Drug for Binge Eating Disorder May Be Near Approval
The first drug for binge eating disorder may be nearing approval at FDA. Shire’s application for lisdexamfetamine (brand name Vyvanse®) for the treatment of binge eating disorder was accepted at the end of September, which means that the FDA is due to rule on their application by February 1.
FDA granted a priority review for their application, which gives optimists one more reason to believe that an approval might be at hand. If FDA does issue an approval, they will be doing so without seeking input from an expert advisory committee — something slightly unusual for a first-in-class approval.
Results from one of the phase 2 studies for this drug application were just published in JAMA Psychiatry. The investigators found “substantial preliminary evidence that lisdexamfetamine may be effective for treatment of moderate to severe BED.”
If and when this drug is approved for binge eating disorder, you can expect that it may be a useful option, but far from a definitive answer to the unmet need for better treatments. Lisdexamfetamine is an amphetamine with important side effects and addictive properties. It’s used with reasonable safety for attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults.
Cognitive behavioral therapy and psychotherapy are cornerstones of treatment for binge eating, but not everyone responds and access to care remains a significant problem. Other classes of drugs, including antidepressants and antiepileptics have been studied, but found to have significant limitations. None of them are FDA-approved for use in binge eating disorder.
Regardless, this is how progress begins with a condition such as binge eating that has only recently been understood as a disease. With one more option, some patients will benefit and that progress will lead to more progress.
Brain Fog, photograph © Distant Hill Gardens / flickr
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