Non-Stimulants Archives

FDA Approves New Nonstimulant Option for Adults with ADHD

ADHD, Adults 18 & Older, Approvals, Children, Expanded Approval, FDA/Regulatory, Monoamine oxidase (MAOI) inhibitors, Non-Stimulants, Primary Endpoints, Therapeutics

The U.S. Food and Drug Administration expanded the indication of Supernus Pharmaceuticals Inc.’s Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.

FDA Approves Novel Non-Stimulant Treatment for ADHD

ADHD, Approvals, Black Box Warning, Clinical Trials, Complete Response Letter, FDA, NDA Resubmission, New Drug Application (NDA), Non-Stimulants, Pediatric, R&D, Shares, Therapeutics

Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

Clinical Therapeutics publishes results of pivotal phase III study of SPN-812 for ADHD

Attention Deficit and Hyperactivity Disorder (ADHD), Children, Clinical Trials, FDA, FDA/Regulatory, Non-Stimulants, PDUFA, Primary Endpoints, R&D

Results of a pivotal phase III study of Supernus Pharmaceuticals’ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics.