The FDA has granted priority review to a supplemental New Drug Application that would expand the use of lisdexamfetamine dimesylate (Vyvanse) to treat adult patients with binge eating disorder.
The FDA has granted priority review to a supplemental New Drug Application (sNDA) that would expand the use of lisdexamfetamine dimesylate (Vyvanse) to treat adult patients with binge eating disorder (BED), Shire plc has announced.
Currently, Vyvanse is only approved for use in attention-deficit/hyperactivity disorder (ADHD). Because the drug can be easily misused or abused, it is classified as a federally controlled substance.
Shire expects the FDA to make a decision on the Vyvanse’s expanded BED indication by February 2015.
“The decision from the FDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need, as there are currently no approved pharmacologic options for these patients,” said Phil Vickers, PhD, head of research and development at Shire, in a press release.
Shire filed the sNDA for the drug after reviewing the results of 2 identically designed randomized controlled Phase 3 studies, which established the efficacy and safety of Vyvanse in BED patients compared to placebo.
The company warned that Vyvanse can potentially cause anxiety, decreased appetite, dry mouth, and dizziness in patients.