Shire drug approved for binge eating disorder
pharmafile | February 2, 2015 | News story | Sales and Marketing | ADHD, FDA, Shire, Vyvanse, binge, eating, lisdexamfetamine dimesylate, obesity
Shire has become the first company to gain FDA approval for a treatment for binge eating disorder (BED) in adults with its ADHD treatment Vyvanse.
The FDA reviewed Vyvanse (lisdexamfetamine dimesylate) under the FDA’s priority review programme, as part of an expedited review for a drug “intended to treat a serious disease or condition and may provide a significant improvement over available therapy”.
Dr Mitchell Mathis who is the director of psychiatry products at the FDA’s Center for Drug Evaluation and Research, says: “Binge eating can cause serious health problems and difficulties with work, home, and social life. The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.”
Vyvanse is a central nervous stimulant that is approved in the US for children aged over six and adults with attention deficit hyperactivity disorder. The licence has now been expanded to include binge eating, which is a recognised as a distinct disorder in the DSM-5 criteria. It is defined as recurring episodes at least once weekly for at least 3 months, of consuming a large amount of food in a short time.
Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. BED is said to be the most common eating disorder in the US, affecting an estimated 2.8 million adults, according to a national survey.
In two clinical trials of 724 adults with moderate-to-severe binge-eating disorder, people who took Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviours – compared to those on a placebo.
“The management of BED is continuously being studied, and though advancements have been made to increase awareness and understanding of this real disorder, rates of diagnosis remain low,” says Professor Susan McElroy, from the University of Cincinnati college of medicine and principal investigator of the Shire BED clinical trials.
The FDA has retained the drug’s status as Vyvanse as a Schedule II controlled substance because the regulator says it has ‘high potential for abuse and dependence’.
Vyvanse and some other similar, sympathomimetic drugs have been linked with serious risks including psychiatric problems, stroke and heart attacks. Central nervous system stimulants like Vyvanse may cause psychotic or manic symptoms, though, even in people without a prior history of psychotic illness.
“Binge eating disorder is the most common adult eating disorder in the US, and we are excited to provide the first FDA-approved treatment for moderate to severe BED in adults,” says Philip Vickers, global head of R&D at Shire. “This new indication for Vyvanse is a critical milestone in the treatment of this condition and reflects our ongoing commitment to address the needs of patients.”
Lilian Anekwe
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