Supernus Pharmaceuticals announced FDA approval of viloxazine extended-release capsules to treat ADHD in patients aged 18 years and older.
The FDA has now given its consent to viloxazine (Qelbree, Supernus), a once-per-day oral nonstimulant for the treatment of ADHD, starting with children aged 6 years, as well as adolescents and adults, a company press release stated.
“As a leader in the field of (treating central nervous system disorders), we are fully committed to better understanding how to treat complex diseases such as ADHD,” Jack Khattar, president and CEO of Supernus said in the release. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just 1 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.”
According to the release, approval was based on positive results from a randomized, double blind, placebo-controlled phase 3 study of the drug.
At a flexible dose between 200 mg and 600 mg, the trial met the primary endpoint of a reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score, which at the end of the study was significantly higher in adults treated with viloxazine vs. placebo.
Significant improvement in AISRS subscale scores of inattention and hyperactivity/impulsivity symptoms were also observed, and the study additionally met the key secondary efficacy endpoint with statistical significance in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was also well tolerated.