With FDA approval, Supernus' Qelbree is the first nonstimulant ADHD med for adults in 2 decades

Approximately 10 million American adults with an attention-deficit hyperactivity disorder (ADHD) diagnosis have a new option for treatment without a stimulant’s side effects, thanks to a new FDA approval for Supernus Pharmaceuticals.

Qelbree, Supernus’ once-a-day pill, won FDA approval Friday to treat adults with ADHD. The approval is the first for a nonstimulant ADHD treatment for adults in 20 years, and it follows the med's original FDA nod in children between the ages of 6 and 17 last April.

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

Studies of the drug proved safety and tolerability, but the most notable difference from other ADHD medications is the abuse potential, or lack thereof—no evidence of abuse potential was found in clinical studies, Supernus said. Nonstimulant ADHD meds don't cause side effects such as agitation or sleeplessness sometimes associated with stimulants.

Qelbree is only the fourth non-controlled ADHD medicine to win FDA approval, Supernus CEO and President Jack Khattar told Fierce Pharma last April. After winning its original FDA approval in children, Supernus started an awareness campaign in the fall.

A nonstimulant ADHD medication for adults hasn’t been introduced since 2002, when the FDA first approved Eli Lilly’s Strattera. The drug lost its patent in 2017, allowing generics to flood the market. 

The adult ADHD population represents a largely untapped market for a nonstimulant therapy, Jefferies analysts wrote in a note last summer. In the children population, about 22% to 23% of patients were on a nonstimulant, compared with just 8% for adults, the analysts wrote at the time.

The analysts have predicted Qelbree could generate about $400 million in sales by 2026.