Shire plc (SHP.L,SHPG) said Friday that the U.S. Food and Drug Administration has approved Vyvanse Capsules, the first and only medication for the treatment of moderate to severe binge eating disorder in adults, shown to significantly reduce the mean number of binge days per week.
Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.
The efficacy of Vyvanse in the treatment of binge eating disorder was demonstrated in two 12-week randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years. The primary efficacy outcome for the two studies was defined as the change from baseline at week 12 in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the baseline visit.
Subjects from both studies on Vyvanse had a statistically significant greater reduction from baseline in mean number of binge days per week at Week 12. In study 1, Vyvanse reduced the mean number of binge days per week from 4.79 at baseline to 0.78 at study endpoint compared with 4.60 to 2.22 for placebo. The least squares mean change from baseline in binge days per week was -3.87 and -2.51 for Vyvanse and placebo, respectively. Similar results were seen in study 2.
Binge eating disorder is the most common eating disorder in the United States, affecting an estimated 2.8 million adults, according to a national survey.
Vyvanse has been in use as a once-daily prescription medication for children, teens, and adults with Attention-Deficit/Hyperactivity Disorder.
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