Supernus Pharmaceuticals has resubmitted its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the NDA in November 2020 indicating that the review cycle for the application was incomplete and that the application was not ready for approval in its present form. Supernus and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission.

The primary issue cited in the SPN-812 CRL relates to the Company’s in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus removed reference to its in-house laboratory and addressed other contents of the CRL.

The FDA will classify the NDA resubmission as Class I or Class II upon acceptance of the resubmission. Generally, a Class I review constitutes a two-month review from the date of resubmission and a Class II review constitutes a six-month review from the date of resubmission.

In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA to the FDA for SPN-812 in adults in the second half of 2021, assuming approval for pediatric patients.