Supernus Pharmaceuticals, Inc. announced on Friday that The US Food and Drug Administration (FDA) approved an extended indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients 18 years of age and older. Supernus Pharmaceuticals, Inc. is a U.S.-based biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system (CNS) diseases. The FDA has now approved Qelbree for the treatment of ADHD in children (from 6 years old), adolescents, and adults.
About 16 million children, adolescents, and adults in the US have ADHD, and while many children with ADHD outgrow it, up to 90% of those diagnosed with childhood ADHD continue to have ADHD as adults.
Greg Mattingly, M.D, founding partner of St. Charles Psychiatric Associates in St. Louis, Mo. Said, “Until today, nonstimulant ADHD options for adults have been very limited”. He further added in his 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”.
Qelbree is a novel nonstimulant taken once a day for a full-day performance. Efficacy and improvement in symptoms were observed at the start of treatment. It has a proven safety and tolerability profile, with no evidence of potential for abuse in clinical studies. The approval is based on the positive results of a randomized, double-blind, placebo-controlled phase III trial of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
Jack Khattar, President and CEO of Supernus Pharmaceuticals, Said that “as a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD”. He further added, “Today’s approval marks a major advance in the treatment of ADHD and marks a significant milestone just one year after the approval of Qelbree to treat pediatric patients. We are proud to bring to market a new nonstimulant alternative for adults after two decades”.
Source: Supernus
