FDA approve first nonstimulant ADHD med for adults in two decades

pharmafile | May 3, 2022 | News story | Manufacturing and Production  

The FDA has expanded the indication of Supernus’s Qelbree to patients aged 18 and older, marking the drug as the first non-stimulant for ADHD in about 20 years to be approved for adults as well as children. Supernus’ Qelbree is a once-a-day capsule previously approved for treating children aged 6 to 17 with ADHD.

The most notable difference from other ADHD medications and Qelbree is the significant difference from other ADHD medications is the abuse potential: no abuse potential for Qelbree was found in clinical studies.

Around 16 million children, adolescents, and adults are diagnosed with ADHD in the US alone.

“Until today, nonstimulant ADHD options for adults have been very limited,” Greg Mattingly, MD, professor of psychopharmacology at the Washington University School of Medicine, and 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.”

Additionally, nonstimulant ADHD meds don’t cause side effects such as agitation or sleeplessness sometimes associated with stimulants. Qelbree met its primary endpoint in the Phase III trial for adults, of reduction in the change from baseline based on AISRS scores, and a statistically significant improvement in inattention and hyperactivity and impulsivity symptoms.

Standard treatments for ADHD involve medication, education, counselling and skills training. Medications usually include stimulants, including amphetamine or methylphenidate, which can lead to abuse. Non-stimulant treatment options such as atomoxetine and antidepressants including bupropion vary in dose per individual, with incorrect dosing potentially leading to health problems and side effects.

Currently, only 8% of adult patients are on a nonstimulant therapy for ADHD, compared to 23% of the child population.

Ana Ovey

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