Supernus drug meets main goal of study in adults with ADHD
(Reuters) – Supernus Pharmaceuticals Inc said on Tuesday its experimental drug for attention deficit hyperactivity disorder (ADHD) met the main goal of a late-stage study in adults.
The drug, SPN-812, was better able to improve symptoms of ADHD compared with a placebo, the company said.
SPN-812 is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in children 6 to 17 years of age.
Last month, the FDA declined to approve the drug for use in children, citing an issue related to the company’s laboratory that conducts analytical testing, which recently moved to a new location.
Supernus on Tuesday said it would meet the FDA in January to discuss the application.
If approved in children, the company said it would file an application with the agency for marketing SPN-812 to adults in the second half of next year.
The adult ADHD patient population represents about half of the total ADHD market in the United States, the company said.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Chris Reese
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