By Jonathan D. Rockoff 

Shire PLC's drug Vyvanse became the first drug approved for sale in the U.S. to treat the estimated 2.8 million adults who have a binge-eating disorder.

Vyvanse has been in use to treat attention-deficit hyperactivity disorder. The Food and Drug Administration greenlighted extending Vyvanse's use to treatment of adults diagnosed as moderate to severe binge eaters, which means they compulsively overeat least three days a week.

Binge eating was only recently added to the American Psychiatric Association's approved list of mental disorders. Patients regularly eat more food than they need, often when they aren't hungry and until they feel uncomfortably full, the FDA said. The condition can lead to weight gain, obesity and related health problems.

In two pivotal studies, binge eating episodes declined to an average of one day a week among patients taking Vyvanse capsules for 12 weeks, down from an average of five days a week, Phil Vickers, Shire's head of research and development, said in an interview.

"The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating," Mitchell Mathis, director of the FDA's division of psychiatry drug products, said in a statement.

Vyvanse, a stimulant, isn't approved or recommended for weight loss, and its use carries the risk of psychiatric problems, such as hallucinations, and vascular complications including stroke and heart attack, the FDA said. The most common side effects that were reported include dry mouth, insomnia and increased heart rate.

An estimated 2.8 million adults in the U.S. are binge eaters, two times more than those who have the eating disorders anorexia and bulimia combined, according to Shire.

For Shire, the approval could eventually add "several hundred million" dollars in sales, and help the company reach its goal of $10 billion in yearly sales by 2020, said Flemming Ornskov, the company's chief executive. Vyvanse is the company's top-selling drug, notching $1.1 billion of the company's $4.3 billion in total sales during the first nine months of last year.

One challenge: increasing the numbers of patients diagnosed as binge eaters. Shire estimates that just 3% of Americans with the disease have been diagnosed under the mental-disorder criteria, Dr. Ornskov said.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

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