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Eating Disorder Treatment Lisdexamfetamine (Vyvanse) Gets Priority Review
The FDA has accepted for filing with a “priority review” designation a supplemental new drug application (sNDA) for lisdexamfetamine dimesylate (Vyvanse, Shire) as a treatment for adults with binge eating disorder (BED). The agency is expected to issue its approval decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
Lisdexamfetamine is a prescription medication currently approved only for the treatment of attention-deficit/hyperactivity disorder (ADHD) in the U.S. The drug is a federally controlled substance (CII) because it can be abused or lead to dependence.
Regulatory approval is being sought for lisdexamfetamine as a treatment option for adults with BED, based on the results of two identically designed randomized placebo-controlled phase III studies that evaluated the efficacy and safety of lisdexamfetamine compared with that of placebo. The results of these studies were announced in November 2013.
BED is an eating disorder recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It is characterized by recurring episodes of eating significantly larger amounts of food in a discrete period (e.g., any 2-hour period) than most people would eat in a similar period under similar circumstances. These episodes are associated with feelings of distress and lack of control (e.g., the sense one cannot stop eating or control what or how much one is eating).
As described in DSM-5, a person with BED may eat much more rapidly than normal; eat until feeling uncomfortably full; eat large amounts of food when not feeling physically hungry; eat alone to hide the behavior due to embarrassment; or experience feelings of disgust, depression, or guilt after a binge episode. In these individuals, binge eating occurs, on average, at least once a week for 3 months. Unlike bulimia nervosa and anorexia nervosa, BED is not associated with the recurrent use of inappropriate behaviors to compensate for binge eating (e.g., purging, excessive exercise, or fasting).
Source: Shire; September 15, 2014.