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.