FDA Action on SPN-812 Expected in April

The US Food and Drug Administration (FDA) has classified the resubmission of the New Drug Application (NDA) for SPN-812 as Class I, setting early April as the Prescription Drug User Fee Act (PDUFA) target action date for the application, Supernus Pharmaceuticals, Inc. announced.

The application seeks approval of SPN-812 (extended-release viloxazine) as a treatment for pediatric attention deficit/hyperactivity disorder (ADHD). It was resubmitted in early February, and Class I reviews typically take 2 months, according to Supernus.

The FDA in November issued a Complete Response Letter (CRL) to the initial NDA, stating that the application was not ready for approval. In a press release, Supernus said the primary issue cited by the FDA was related to the company’s recently relocated in-house analytical testing laboratory.

SPN-812, a novel nonstimulant, is a serotonin norepinephrine modulating agent, with viloxazine hydrochloride as the active ingredient. If it receives FDA approval, Supernus plans to launch the product in the second quarter of 2021.

The company also plans to submit a supplemental NDA in the second half of 2021 for the treatment of adults with ADHD, if the application for the treatment of pediatric ADHD is approved. In December, the company announced positive results from a phase 3 study of the compound in adults with ADHD.

—Terri Airov

Reference
Supernus receives FDA notice assigning early April 2021 PDUFA date for SPN-812 NDA [press release]. Rockville, MD: Supernus Pharmaceuticals, Inc.; February 22, 2021.