Supernus Pharma announces receipt from the FDA of a Refusal to File letter for SPN 830 a proposed treatment for Parkinson's disease.

Supernus Pharmaceuticals, Inc. announced the regulatory update SPN 830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson’s disease. The Company received a Refusal to File (RTF) letter from the FDA regarding its NDA for SPN 830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson’s disease (PD). In its review of the NDA, which was submitted in September 2020, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. The Company plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN 830.