FDA Issues CRL for ADHD Treatment SPN-812

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional data for SPN-812, a viloxazine hydrochloride treatment for attention-deficit/ hyperactivity disorder (ADHD).

The treatment, developed by Supernus Pharmaceuticals, was aimed at pediatric patients between 6-17 years old.

The FDA’s decision not to approve the New Drug Application (NDA) for SPN-812 was based on the pharmaceutical company’s decision to move their in-house laboratory that conducts analytical testing to a new location. On the other hand, the FDA did not identify safety or efficacy issues during the review.

Supernus has indicated they plan to discuss with the FDA the contents of the letter and clarify that the application does not solely rely on the facility in question for product release. The company has also indicated they plan to discuss with the agency the steps required to resubmit the NDA.

“On SPN-812, we look forward to collaborating with the FDA to clarify and resolve the facility matter and put SPN-812 back on track to help the millions of children and adolescents in the U.S. with ADHD,” Jack Khattar, President and CEO of Supernus, said in a statement.

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 to 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.