Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration announced on Jan. 30.
Approval was based on the results of two studies of 724 adults with moderate to severe binge-eating disorder. The studies found that the number of days per week participants engaged in binge-eating behavior decreased among those on Vyvanse, compared with those on placebo. Those on the drug also had fewer obsessive-compulsive binge-eating behaviors. Dry mouth, insomnia, increased heart rate, jitteriness, constipation, and anxiety were among the most common adverse effects associated with the drug in the studies.
This approval “provides physicians and patients with an effective option to help curb episodes of binge eating,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Binge eating can cause serious health problems and difficulties with work, home, and social life.”
Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons
Lisdexamfetamine was first approved in 2007 as a treatment for attention-deficit/hyperactivity disorder in patients aged 6 years and older, and is a Schedule II controlled substance because of its high potential for abuse and dependence.
Prescriptions for the drug are dispensed with a Medication Guide, which provides information about its use and risks. “The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness,” the FDA statement said.
Vyvanse, manufactured by Shire US, has not been studied as a weight loss agent “and is not approved for, or recommended for, weight loss,” according to the statement.
Serious adverse events thought to be associated with Vyvanse should be reported to the FDA’s MedWatch program at 800-332-1088.