FDA Approves Supernus Pharmaceuticals’ Qelbree For Treatment Of ADHD In Adults

Supernus Pharmaceuticals, Inc. (SUPN) on Monday announced that the U.S. Food and Drug Administration has approved its expanded indication for Qelbree for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.

The FDA has now approved Qelbree for the treatment of ADHD in children, adolescents and adults.

According to CDC, ADHD is one of the most common neurodevelopmental disorders of childhood. It is usually first diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active.

Approximately 16 million children, adolescents, and adults have ADHD in the U.S. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.

“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, M.D., founding partner of St. Charles Psychiatric Associates in St. Louis, Mo. “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.”

According to the company, the approval is based on positive results from a late-stage study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.

“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after two decades.”

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