Supernus Pharmaceuticals, Inc. has resubmitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of SPN-812 for the treatment of pediatric attention deficit/hyperactivity disorder (ADHD).
In November, the FDA issued a Complete Response Letter (CRL) to the initial NDA, saying the application was not ready for approval. According to a press release from Supernus, the primary issue cited in the letter was related to the company’s in-house laboratory that conducts analytical testing, which had recently been relocated.
SPN-812 (extended-release viloxazine) is a serotonin norepinephrine modulating agent which Supernus is developing as a novel nonstimulant for the treatment of ADHD. The active ingredient, viloxazine hydrochloride, was marketed in Europe as an antidepressant for several years and has an extensive safety record there, according to the company.
Supernus met with the FDA in January to discuss the letter and the requirements for the NDA resubmission. According to the company, if the FDA accepts the resubmission, the agency will then classify it as Class I or Class II. In general, Class I reviews take 2 months and Class II reviews are completed within 6 months, according to Supernus.
If SPN-812 is approved for pediatric patients, Supernus plans to submit a supplemental NDA in the second half of 2021 for the treatment of adults with ADHD. The company in December announced positive results from a phase 3 study of SPN-812 in adults with ADHD.