
“The decision from the FDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need as there are currently no approved pharmacologic options for these patients,” said Phil Vickers, head of research and development, Shire.
Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat ADHD.
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
Shire is seeking approval for Vyvanse as a treatment option for adults with BED based on the results of two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo, previously announced in a press release dated November 5, 2013.
Date: September 15, 2014
Source: Shire