Shire seeks FDA approval for chewable version of ADHD drug Vyvanse

FDA
Shire's Vyvanse ADHD drug.

Shire ($SHPG) is looking for FDA approval of a new, chewable tablet of its popular ADHD drug Vyvanse that is targeted to children and adolescents.

In its New Drug Application to the regulatory agency, the drugmaker said the tablets of lisdexamfetamine dimesylate can be swallowed whole or consumed by opening and mixing the entire contents of the capsule in water, orange juice or yogurt. Additionally, the new formulation could be used by adults with difficulty swallowing or opening capsules, the company said.

Currently, Vyvanse is used for the treatment of ADHD in patients six years and older as well as for treating moderate to severe binge eating in adults though it is not indicated for weight loss. It is not known if the drug is safe for use to treat obesity.

“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,” Perry Sternberg, head of Shire’s Neuroscience, Ophthalmics and Commercial Excellence department, said in a release.

Two studies were used and cited in the application, the company said. If approved by the FDA, patients would ingest the medication once daily, in the morning.

The Ireland-based company recently affirmed its merger with Baxalta is still a go despite news of Pfizer’s ($PFE) cancelled merger with Allergan ($AGN) amid a U.S. Treasury tax crackdown. Shire CEO Flemming Ornskov said last week he expects the merger deal to be completed by the middle of the year.

 

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