New Formulation of Vyvanse Submitted to FDA for Review

Shire announced that it has submitted to the Food and Drug Administration (FDA) a New Drug Application (NDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.

Vyvanse capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ≥6 years old and for the treatment of moderate to severe Binge Eating Disorder (BED) in adults. The proposed indications for the chewable formulation are the same as the currently FDA-approved indications for the capsules.

The NDA application is supported by data from two clinical pharmacology studies (SHP489-126 and SHP489-127) which demonstrated bioequivalence of the chewable tablet to the capsule formulation. Based on these studies, Vyvanse chewable tablet shows comparable clinical profile to the current capsule formulation.

Vyvanse is a controlled substance (CII) CNS stimulant.

Want to read more?