Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Adults living with attention deficit hyperactivity disorder (ADHD) saw new hope this weekend as the U.S. Food and Drug Administration expanded the indication of Supernus’s Qelbree to patients ages 18 and older.
Qelbree (viloxazine extended-release capsules) is a novel nonstimulant that is taken once a day for full exposure. Results from the Phase III trial in adults demonstrated efficacy, tolerability and safety, with no evidence of abuse potential. Notably, Qelbree is the first FDA approval of a novel non-stimulant treatment for ADHD in 20 years.
The randomized, double-blind, placebo-controlled study gave patients a daily flexible dose of 200 mg to 600 mg and measured outcomes based on the Adult ADHD Investigator Symptom Rating Scale (AISRS).
At the end of the trial, Qelbree showed the ability to meet the primary endpoint of reduction in the change from baseline based on AISRS scores and a statistically significant improvement in inattention and hyperactivity/impulsivity symptoms. After six weeks, the study also met the key secondary endpoint of a significant change from baseline based on the Clinical Global Impression - Severity of Illness scale.
The drug was first approved for the 6- to 17-year-old age range in April 2021.
“Until today, nonstimulant ADHD options for adults have been very limited. 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,” noted Greg Mattingly, MD, the founding partner of St. Charles Psychiatric Associates in St. Louis, MO, in a statement.
Around 16 million children, adolescents and adults are diagnosed with ADHD in the U.S. alone, and up to 90% of those who have the condition as children carry it into adulthood.
Standard treatments typically involve medication, education, counseling and skills training. Medications usually include stimulants, such as those that include amphetamine or methylphenidate, which can later lead to abuse. Some medications involve non-stimulants like atomoxetine and antidepressants like bupropion. However, dosages vary per individual, and incorrect dosing can cause health problems and side effects.
“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,” commented Jack Khattar, the president and chief executive of Supernus Pharmaceuticals.
Supernus cautions that Qelbree might increase thoughts of suicide and similar actions in the first few months, so careful monitoring of moods, behaviors, feelings and thoughts is needed. The drug should also not be taken with certain antidepressants, particularly those containing a monoamine oxidase inhibitor or MAOI or certain asthma drugs.
