ADHD drug for adults gets approved

Photo of Dominic Genetti
Pile of white pills on blue background

Pile of white pills on blue background

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An estimated 10 million adults suffer from attention-deficit/hyperactivity disorder in the United States and a new drug from the FDA may help those diagnosed cope with it.

The approval of Qelbree was announced May 2 by Supernus Pharmaceuticals, Inc. based in Maryland. This is the first approval of its kind in 20 years.

Qelbree is a non-stimulant taken once daily for full-day exposure, its approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD. 

"Until today, non-stimulant ADHD options for adults have been very limited," Dr. Greg Mattingly, founding partner of St. Charles Psychiatric Associates in St. Louis, said. "This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms."

In the flexible-dose study of adults 18 to 65 years of age, ADHD symptom score reductions were statistically significant in the Qelbree patients, beginning at the second week of taking the medication.