Supernus announces a Complete Response Letter for SPN-812 a treatment for ADHD.

Supernus Pharmaceuticals, Inc. announced regulatory updates for SPN 812 (viloxazine hydrochloride) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN 812 for the treatment of ADHD in pediatric patients 6 to 17 years of age. The FDA issued a CRL to indicate that the review cycle for the application is complete and that the application is not ready for approval in its present form. 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. The Company plans to discuss with the FDA the contents of the CRL and clarify to the FDA that the application does not rely solely on this facility for product release. The company plans to discuss with the agency the steps required for the resubmission of the NDA for SPN-812. Importantly, no clinical safety or efficacy issues were identified during the review.