Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

Rhea-AI Summary

Supernus Pharmaceuticals (Nasdaq: SUPN) has announced that the FDA has accepted the resubmission of the new drug application (NDA) for SPN-830, its apomorphine infusion device. This device is designed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease. The FDA has set a PDUFA target action date of February 1, 2025 for the review of the application. This development marks a significant step forward in Supernus's efforts to bring a new treatment option to market for Parkinson's disease patients experiencing motor fluctuations.

Positive

• FDA acceptance of the resubmitted NDA for SPN-830
• PDUFA date set for February 1, 2025, providing a clear timeline for potential approval
• Potential new treatment option for Parkinson's disease patients with motor fluctuations

Negative

• Long waiting period until the PDUFA date (February 1, 2025)
• No guarantee of FDA approval for SPN-830

Insights

Medical Research Analyst

The FDA's acceptance of Supernus Pharmaceuticals' NDA for SPN-830 marks a significant milestone in the development of continuous treatment options for Parkinson's disease. This apomorphine infusion device addresses a critical need in managing motor fluctuations, potentially offering patients more consistent symptom control.

The PDUFA date of February 1, 2025 sets a clear timeline for potential market entry. If approved, SPN-830 could reshape the treatment landscape for Parkinson's, providing an alternative to oral medications that often lead to "wearing off" effects. The continuous delivery method could minimize OFF episodes, improving patients' quality of life.

However, investors should note that FDA approval is not guaranteed and the 18-month review period suggests a complex evaluation process. The extended timeline may reflect the FDA's thorough examination of the device's safety and efficacy data.

Financial Analyst

Supernus Pharmaceuticals' NDA acceptance for SPN-830 is a positive development for the company's pipeline and potential revenue streams. If approved, this novel delivery system for apomorphine could capture a significant portion of the Parkinson's disease market, estimated to be worth over $8 billion globally by 2026.

Investors should consider the long-term impact on Supernus' financials. While the February 2025 PDUFA date means no immediate revenue boost, it provides a clear target for market preparation. The company may need to allocate resources for pre-launch activities, potentially impacting short-term expenses.

The acceptance also validates Supernus' CNS focus, potentially attracting partnerships or investment in their broader pipeline. However, the extended review period might indicate regulatory complexities, which could affect investor sentiment in the near term.

PDUFA Target Action Date of February 1, 2025

ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD). The resubmission is now considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates, including SPN-830; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

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

FAQ

What is the PDUFA date for Supernus Pharmaceuticals' SPN-830 device?

The PDUFA (Prescription Drug User Fee Act) target action date for Supernus Pharmaceuticals' SPN-830 apomorphine infusion device is February 1, 2025.

What is the purpose of Supernus Pharmaceuticals' SPN-830 device?

SPN-830 is an apomorphine infusion device designed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease patients.

Has the FDA accepted Supernus Pharmaceuticals' NDA for SPN-830?

Yes, the FDA has acknowledged and accepted the resubmission of the new drug application (NDA) for Supernus Pharmaceuticals' SPN-830 apomorphine infusion device.

What is Supernus Pharmaceuticals' stock symbol?

Supernus Pharmaceuticals' stock symbol is SUPN, and it is listed on the Nasdaq stock exchange.