Binge eating disorder drug approved

Binge eating disorder drug approved

Risks include sudden death, psychiatric problems, stroke or heart attacks.

Binge eating disorder, a condition often accompanied by other psychological conditions such as depression, will now be treatable in the United States with a prescribed drug already used for Attention Deficit Hyperactivity Disorder (ADHD).  The U.S. Food and Drug Administration (FDA) expanded the approved uses of lisdexamfetamine dimesylate (Vyvanse), offering possible help to adults who deal with binge-eating disorder.

In a press release issued by the FDA, Mitchell Mathis, M.D. said that eating in binges can be the cause of “serious health problems and difficulties with work, home, and social life.” Mathis is director of the FDA’s Center for Drug Evaluation and Research’s Psychiatry Products division. He characterized the drug as “an effective option” to curb episodes of binge eating.

Patients suffering under the disorder compulsively overeat, consuming higher amounts of food than normal and also feel a sense of being out of control. They eat when not hungry and feel uncomfortably full. Social isolation can occur as patients may feel shame at their overconsumption. Health problems and weight gain or obesity can result.

Vyvanse is a once-a-day pill that was originally approved by the FDA in 2007 for ADHD. More recently, the drug received priority review by the FDA, using a program that allows expedited review of drugs which could provide significant improvements for people with serious conditions. Vyvnase

Vyvanse is marketed by Shire U.S., Inc., which is based in Wayne, Pennsylvania. The company is based on the island of Jersey and led by Chief Executive Officer Flemming Ornskov, a Dane, who previously worked for Bayer.

Two clinical studies which looked at a total of 724 adults with bing eating disorder showed patients experiencing a decreased number of binge eating days as well as fewer binge eating behaviors when compared with a placebo. Risks of using Vyvanse include sudden death for people with heart problems or defects, psychiatric problems and adult stroke or heart attacks. Vyvnase is an amphetamine, acting as a stimulant to the central nervous system. As such, it could cause manic or psychotic symptoms like delusional thinking or hallucinations, even for those without a psychotic illness history.

Common side effects include insomnia, dry mouth, constipation, jitteriness, anxiety, and increased heart rate. Such side effects are sometimes associated with weight loss drugs but Vyvanse has not approved for this use.

Vyvanse generated sales in the first nine months of last year of more than $1 billion. Shire’s CEO Ornskov said that his company’s goal is to $10 billion in sales by 2020 and, of that, his expectation is to see $200 million to $300 million of that total to come from Vyvanse sales for binge-eating.

As a Schedule II controlled substance, users of Vyvnase may become severely dependent. Such drugs are considered to have a high potential for abuse.

The FDA is division of the U.S. Department of Health and Human Services, charged with protecting public health. One way it attempts to do this is by certifying the effectiveness, safety and security drugs, vaccines and other biological products for human or animal use. Additionally, the agency also charged with the safety of the country’s food supply, dietary supplements, cosmetics, dietary supplements, as well as items that emit electronic radiation and the regulation of tobacco products.

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