The US Food and Drug Administration (FDA) has approved an expanded indication for Supernus Pharmaceuticals’ Qelbree (viloxazine extended-release capsules) to treat attention deficit hyperactivity disorder (ADHD) in adult patients of the age 18 and above.
Qelbree now received approval for ADHD treatment in children starting at the age of six, adolescents as well as adults.
Supernus Pharmaceuticals president and CEO Jack Khattar said: “As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD.
“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 paediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after two decades.”
The approval of Qelbree, a new nonstimulant taken once-daily for full-day exposure, is based on positive results obtained from a Phase III study in adults with ADHD.
It represents the first approval of a new nonstimulant treatment for adults in 20 years.
Efficacy and symptom improvement was observed early when these adults received the treatment, which has a safety and tolerability profile.
No evidence of abuse potential was reported in clinical studies.
At a daily flexible-dose between 200mg and 600mg, the randomised, double blind, placebo-controlled Phase III trial met the primary endpoint.
The study also met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6.
The active dose was found to be well tolerated.