Supernus Pharmaceuticals Announces FDA Review for SPN-830 Device
Supernus Pharmaceuticals Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA
PDUFA Target Action Date of February 1, 2025
ROCKVILLE, Md. — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company dedicated to the development and commercialization of products for treating central nervous system (CNS) disorders, has reported 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 (SPN-830). This device targets continuous treatment for motor fluctuations (OFF episodes) associated with Parkinson’s disease (PD). The resubmission has been officially filed, with a user fee goal date (PDUFA date) set for February 1, 2025.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company that specializes in creating and marketing treatments for central nervous system (CNS) diseases. The company's mission is to address serious medical needs within the CNS domain through innovative products.
The company boasts a diverse neuroscience portfolio that includes approved therapies for 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. Supernus is also advancing several promising CNS product candidates that could provide new treatment options for hypomobility in PD, epilepsy, depression, and a range of 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 designed for the continuous treatment of motor fluctuations, specifically OFF episodes, in patients with Parkinson’s disease.
2. What is the significance of the FDA's acceptance of the NDA?
The FDA's acceptance of the NDA indicates that the application for the SPN-830 device meets the necessary criteria for review, marking an important step towards 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 scheduled for February 1, 2025.
4. What products are included in Supernus Pharmaceuticals' portfolio?
Supernus Pharmaceuticals has a diverse range of products for treating various CNS disorders, including therapies for epilepsy, migraine, ADHD, and Parkinson's disease-related conditions.
5. How can I contact Supernus Pharmaceuticals for more information?
For more information, you can contact Jack A. Khattar or Timothy C. Dec at Supernus Pharmaceuticals by calling (301) 838-2591.
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