Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets

New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules.

In the US, Vyvanse capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages six and above and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known whether Vyvanse is safe and effective for the treatment of obesity. The proposed indications for Vyvanse chewable tablets are the same as the currently FDA-approved indications for Vyvanse capsules.

“Patients are always our top priority at Shire. We’re looking forward to FDA review of this application because Vyvanse chewable tablets provide an additional option for patients who may prefer taking medication in this manner,” said Perry Sternberg, Head of Neuroscience, Ophthalmics and Commercial Excellence, Shire.

Two clinical pharmacology studies (SHP489-126 and SHP489-127) formed the basis of this application. Study SHP489-126 demonstrated that the chewable tablet formulation is bioequivalent to the capsule formulation after a single oral dose administration of each. Study SHP489-127 established that the chewable tablet formulation is bioequivalent in both a fasting and non-fasting state. Based on these clinical pharmacology studies, the clinical profile of Vyvanse chewable tablets is thought to be comparable to the current formulation.

The Vyvanse chewable tablet has not been approved in any country. The tablet would be administered orally, once daily in the morning.