The Rockville, Md., biopharmaceutical company's drug is called Qelbree, generically viloxazine.
The extended-release capsules treat attention-deficit hyperactivity disorder in kids 6 to 17 years old, Supernus said in a statement on Friday.
Supernus shares at last check were trading 11% higher at $29,55.
The drug was cleared for marketing following “four Phase 3 clinical trials that studied more than 1,000 pediatric patients" in that age range, Supernus said.
Qelbree is not a controlled substance, and it has "proven efficacy and a tolerable safety profile," Jack A. Khattar, Supernus's president and chief executive, said.
"The right treatment is key for children and adolescents, as they grow and navigate school and social relationships,” said Andrew J. Cutler, clinical associate professor of psychiatry at State University of New York’s Upstate Medical University in Syracuse and chief medical officer of the Neuroscience Education Institute.
“This approval offers a novel once-a-day sprinkleable non-stimulant" treatment for children and adolescents with ADHD.
Cutler is a clinical-trial investigator for Qelbree.
The company told TheStreet that the drug comes as a capsule. It is sprinkleable because if patients have a hard time swallowing, the capsule can be opened and the drug is then sprinkled on top of food.
Supernus did studies of sprinkling the drug on top of applesauce. “Because kids really don’t want to swallow pills. It’s easier to do that than to try to get the kids to take a pill,” the company said.
In December, the company also had reported progress from a Phase 3 trial of Qelbree in adults with ADHD.
The company said then that it planned to submit a supplemental new drug application to the FDA in second-half 2021 to enable adults to use Qelbree.
Supernus Pharmaceuticals' drug development and commercialization is centered on central nervous system diseases, including ADHD, epilepsy, migraines, reduced range of motion resulting from Parkinson’s disease, and other disorders.
The company says it is working on a “broad range of novel [central-nervous-system] product candidates."