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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
The approval comes after Supernus resubmitted an application to address issues outlined in a FDA CRL.
The US Food and Drug Administration has approved the first novel non-stimulant medication for attention deficit/hyperactivity disorder (ADHD) in more than a decade in SPN-812 (Qelbree).
The approval allows Supernus Pharmaceuticals to move forward with the viloxazine extended-release capsules for pediatric ADHD patients between 6-17 years old.
The approval is based on data from 4 phase 3 clinical trials involving more than 1000 pediatric patients.
“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals, in a statement. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research.”
The approval comes a few months after the FDA issued a Complete Response Letter for additional data for the viloxazine hydrochloride treatment.
The FDA’s decision not to approve the NDA was based on the pharmaceutical company’s decision to move their in-house laboratory that conducts analytical testing to a new location. The FDA did not identify any safety or efficacy issues during the review of the application.
Supernus met with the FDA in a January Type A meeting and resubmitted the application in February.
In 2019, investigators of SPN-812 presented new data from a phase 3 study, touting positive topline results. Patients receiving SPN-812 400 mg experienced a significant decrease in ADHD-RS-5 from baseline compared to those receiving placebo.
The double-blind study included 297 patients 12-17 years of age who were diagnosed with ADHD. Participants were randomized to SPN-812 400 mg, SPN-812 600 mg, or placebo.
Treatments were given orally and daily over 7 weeks, with 1 week of titration for the SPN-812 400 mg group and 2 weeks of titration for the SPN-812 600 mg group.
After 7 weeks, the SPN-812 400 mg treatment reached statistical significance compared to placebo in the primary endpoint, change from baseline in ADHD-RS-5 total score. Participants receiving SPN-812 400 mg had a -18.3 LS Mean change from baseline (P = .0082) vs. LS Mean change of -13.2 from baseline for those receiving placebo.