Supernus Pharmaceuticals Announces FDA Acceptance of SPN-830 Apomorphine Infusion Device NDA
PDUFA Target Action Date: February 1, 2025
ROCKVILLE, Md. — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing treatments for central nervous system (CNS) disorders, has announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the new drug application (NDA) for its innovative apomorphine infusion device, known as SPN-830. This device aims to provide continuous treatment for motor fluctuations, specifically OFF episodes, in individuals with Parkinson’s disease (PD). The resubmission has been officially filed, and the user fee goal date (PDUFA date) is set for February 1, 2025.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is dedicated to developing and marketing treatments for CNS diseases. The company’s mission is to meet significant medical needs within the CNS field through innovative solutions.
With a diverse neuroscience portfolio, Supernus offers approved therapies for conditions such as epilepsy, migraine, attention-deficit/hyperactivity disorder (ADHD), hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, and levodopa-induced dyskinesia in patients with PD. Additionally, Supernus is working on several promising CNS product candidates that may offer new treatment options for hypomobility in PD, epilepsy, depression, and various other CNS disorders.
For more information, please visit www.supernus.com.
Contact Information
CONTACT:
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591
Or
INVESTOR CONTACT:
Peter Vozzo
ICR Westwicke
(443) 213-0505
peter.vozzo@westwicke.com
Frequently Asked Questions
1. What is the SPN-830 device used for?
The SPN-830 device is intended for continuous treatment of motor fluctuations, particularly OFF episodes, in patients diagnosed with Parkinson’s disease.
2. What does the FDA's acceptance of the NDA mean?
The FDA's acceptance of the NDA signifies that the application for the SPN-830 device has met the necessary criteria for review, representing a crucial step toward potential regulatory approval.
3. When is the PDUFA date for the SPN-830 device?
The user fee goal date (PDUFA date) for the SPN-830 device is set for February 1, 2025.
4. What types of products does Supernus Pharmaceuticals offer?
Supernus Pharmaceuticals has a wide range of products aimed at treating various CNS disorders, including medications for epilepsy, migraine, ADHD, and conditions related to Parkinson's disease.
5. How can I reach Supernus Pharmaceuticals for additional information?
For more details, you can contact Jack A. Khattar or Timothy C. Dec at Supernus Pharmaceuticals by calling (301) 838-2591.
