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
Subscribe to WSJ: http://online.wsj.com?mod=djnwires