Supernus has resubmitted a New Drug Application to the US Food and Drug Administration for SPN-812, a potential treatment for attention deficit/hyperactivity disorder (ADHD) in pediatric patients.
In November, the FDA issued a Complete Response Letter (CRL), requesting additional data on 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 last month in a Type A meeting to discuss what was needed for resubmission.
In the resubmission, Supernus removed any references to the in-house laboratory and addressed other content outlines in the CRL.
Upon acceptance, the FDA is expected to classify the NDA resubmission as either Class I, which includes a two-month review period on the data in the new application or Class II, which constitutes a six-month review from the data.
Positive Trial Results
Supernus also announced positive results in December from a phase 3 trial testing SPN-812 in adult ADHD patients. The company expects to submit a supplemental NDA for the treatment of adults in the second half of 2021 if the agency first approves SPN-812 for pediatric patients.
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.