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.