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The FDA expanded the approval of viloxazine extended-release capsules (Qelbree) to include adults with ADHD, .

Now indicated for adults ages 18 and older, viloxazine is the first nonstimulant ADHD option for adults in 20 years. The agent was ages of 6 to 17.

"Until today, nonstimulant ADHD options for adults have been very limited," said Greg Mattingly, MD, of St. Charles Psychiatric Associates in St. Louis, 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."

Acting as a novel selective norepinephrine reuptake inhibitor, viloxazine is available in 100-, 150- and 200-mg oral capsules that can be swallowed whole or the contents sprinkled onto certain foods.

The newly approved adult indication comes with a recommended starting dosage of 200 mg once daily and a maximum dosage of 600 mg once daily.

According to the label, viloxazine may also increase blood pressure and heart rate. It may also activate mania or hypomania, so it's recommended patients be screened for bipolar disorder prior to treatment.

The label also carries a boxed warning label regarding suicidal thoughts and behaviors, recommending to closely monitor all patients for worsening or newly emerging suicidal thoughts and behaviors. It's also contraindicated for use with monoamine oxidase inhibitors and sensitive CYP1A2 substrates or CYP1A2 substrates.

Underpinning the approval was a that demonstrated that a flexible dose between 200 to 600 mg daily led to significant ADHD symptom improvement, measured by the ADHD Investigator Symptom Rating Scale, as early as the second week of treatment. At week 6 of treatment, those on active treatment saw a 15.5-point change in score from baseline versus an 11.7-point drop with placebo. The drug also showed a significant advantage in change from baseline in the Clinical Global Impression - Severity of Illness Scale score at week 6.

The most common treatment-related adverse events in the trial were insomnia, fatigue, decreased appetite, nausea, headache, and dry mouth.

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