FDA Again Denies Approval for Supernus' Parkinson's Device
Supernus Pharmaceuticals has received a Complete Response Letter (CRL) from the FDA regarding their New Drug Application (NDA) for SPN-830, a drug-device combination intended to treat movement-related symptoms of Parkinson's disease. The FDA's decision, which marks the second rejection of the treatment, cites issues with product quality and the master file for the proprietary infusion device. No clinical safety or efficacy concerns were identified that would necessitate additional conditions for approval.
The company, whose shares dropped by 9% in early trade following the announcement, intends to work with the device's manufacturer to address the FDA's concerns and resubmit the application. Supernus is focused on the development of this pump-based treatment designed to deliver apomorphine under the skin to control "off episodes" experienced by Parkinson's patients when the effects of their medication wane.
Despite the setback, Supernus maintains a gross profit margin of 86.21% with a reported revenue decline of 8.95% in the last 12 months as of Q1 2023. The company's high shareholder yield continues to be of potential interest to investors seeking returns through various distribution channels. Supernus' efforts to market the pump treatment face further complications due to the FDA's latest response, yet the company remains committed to advancing the treatment's availability for those affected by Parkinson's disease.
