Supernus Pharmaceuticals—a company focused on developing and commercializing products to treat central nervous system (CNS) conditions, has announced the US Food and Drug Administration (FDA) has approved an expanded indication for Qelbree (viloxazine extended-release capsules). The drug—indicated for treatment of adult attention deficit hyperactivity disorder (ADHD) patients—is now approved to treat ADHD in children (starting at age 6), as well as teens and adults.
Approximately 16m children, adolescents, and adults in the US are living with ADHD. While many patients diagnosed as children eventually outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.
"Until today, non-stimulant ADHD options for adults have been very limited," said Greg Mattingly, founding partner of St. Charles Psychiatric Associates in St. Louis, Missouri. "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."
Qelbree is a novel non-stimulant taken once daily for full-day exposure. According to Supernus, efficacy and symptom improvement were observed early in treatment. The drug reportedly has a proven safety and tolerability profile, with no evidence of abuse potential in clinical studies. The approval is based on positive results from a randomized, double-blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel non-stimulant treatment for adults in 20 years.
"As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD," said Jack Khattar, president and CEO of Supernus Pharmaceuticals. "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 non-stimulant option for adults into the market after two decades."
At a daily flexible dose between 200mg to 600mg, the Phase III trial reportedly met the primary endpoint showing a reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at end of the study was statistically significantly greater in adults treated with Qelbree versus placebo (p=0.0040).
Significant improvement in AISRS subscale scores of inattention and hyperactivity/impulsivity symptoms was also observed in the study. Moreover, the study 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 well tolerated.