ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).
At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.
SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.