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Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms
Topline results from Phase IV study demonstrate Qelbree is safe and well-tolerated, and significantly improved efficacy outcomes when added to a stimulant
About this update from Supernus Pharmaceuticals, Inc.
[{"type":"text","content":"Topline results from Phase IV study demonstrate Qelbree is safe and well-tolerated, and significantly improved efficacy outcomes when added to a stimulant medication in pediatric patients with ADHDFinal long-term data show Qelbree consistently improved symptoms and executive function in adults with ADHD, with safety and tolerability similar to the short-term pivotal adult Phase III trial ROCKVILLE, Md., Sept. 09, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announces the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree. “While ADHD is recognized as one of the most common psychiatric diagnoses, affecting approximately 16.1 million individuals in the United States, patients are in need of alternative or additional options to stimulants that allow them to manage their symptoms with a safe and tolerable treatment option,” says Jonathan Rubin, Chief Medical Officer and Senior Vice President of Research & Development. “The new Qelbree data presented during Psych Congress 2023 reinforce the efficacy and safety of our novel nonstimulant treatment in addition to existing stimulant therapy in children ages 6 and older with ADHD and in a long-term setting in adults with ADHD.” Results from Phase IV Safety Trial of Concomitant Use with Psychostimulants in Children and Adolescents with ADHD When added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile as well as a significant improvement in ADHD symptoms in pediatric patients (6-17 years), regardless of timing of dosing. In an eight-week, Phase IV, open-label study, children (ages 6-11) and adolescents (ages 12-17) took psychostimulants at least five days a week in the morning throughout the duration of the study, and received Qelbree once-daily in the morning through week four and then switched to evening dosing through week eight; children received 100mg per day of Qelbree at week one and were optimized to 100-400mg per day, and adolescents received 200mg per day of Qelbree at week one ...