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.

RELATED: Triple-Bead Mixed Amphetamine Salts Shows Promise in ADHD Study 

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.

Continue Reading

Vyvanse is a controlled substance (CII) CNS stimulant.

For more information call (800) 536-7878 or visit