Qelbree (viloxazine extended-release capsules), a New Non-Controlled Substance, Now Available for the Treatment of ADHD in Pediatric Patients 6-17 Years of Age
ROCKVILLE, Md., May 24, 2021 (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, today announced that its recent U.S. Food and Drug Administration (FDA) approved treatment Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age, is now available.
"The availability of Qelbree™ has helped to create a shift in the way providers can approach treatment for children and teens with ADHD," said Ann Childress, M.D, psychiatrist with a subspecialty in child and adolescent psychiatry, Clinical Researcher, and President of the Center for Psychiatry and Behavioral Medicine in Las Vegas. "Many of my patients and their caregivers seek non-stimulant options as we work together to develop a treatment regimen. Having access to a once-daily capsule - that can even be sprinkled on food - with proven long-acting efficacy, as well as early onset of improvement, is sure to make an impact on children and teens looking for new treatment options to manage their ADHD."
Supernus has developed a robust patient access program to support those who qualify for treatment. In addition to a co-pay assistance program, the Company has launched a sampling program and full support hub. Supernus is committed to helping patients access Qelbree.
"At Supernus, we continue to be focused on advancing treatments across the CNS landscape, including the treatment of ADHD," said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "As a non-controlled substance that has a unique profile of proven efficacy, safety, and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication. We look forward to being able to support the ADHD community as we officially launch Qelbree in the market alongside our patient support programs to improve access to this important treatment option."
In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the third quarter of 2021.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in Parkinson's disease, epilepsy, depression, and rare CNS disorders.
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