Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Rhea-AI Summary

Supernus Pharmaceuticals (NASDAQ: SUPN) has resubmitted its New Drug Application (NDA) for the apomorphine infusion device (SPN-830) to treat motor fluctuations in Parkinson’s Disease (PD). This follows a Refusal to File (RTF) letter from the FDA in November 2020, which noted the application was incomplete. The resubmission is significant as SPN-830 could provide a novel treatment option for PD patients, offering a less invasive alternative for managing OFF episodes. The company remains focused on CNS disease treatments, with various approved and developing products in their pipeline.

Positive

• Resubmission of NDA for SPN-830 could lead to FDA approval.
• SPN-830 offers a novel treatment approach for Parkinson’s Disease patients.
• Development and commercialization focus on CNS diseases enhances market positioning.

Negative

• Previous NDA submission was rejected by the FDA due to incompleteness.
• Regulatory approval timeline remains uncertain, impacting market expectations.

ROCKVILLE, Md., Dec. 08, 2021 (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 it has resubmitted its 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).

Following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in November 2020 indicating that the NDA was not sufficiently complete to permit a substantive review. The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.

“SPN-830 is an important product candidate which, if approved by the FDA, represents a novel approach for PD patients,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “We believe the continuous subcutaneous infusion of apomorphine for the treatment of motor fluctuations (OFF episodes) can be an attractive alternative for patients who are seeking less invasive options.”

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 PD, cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. 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; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products; 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 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.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

or

INVESTOR CONTACT
Peter Vozzo
ICR/Westwicke
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com

 

FAQ

What is SPN-830 and why is it important for Supernus Pharmaceuticals?

SPN-830 is an apomorphine infusion device aimed at treating motor fluctuations in Parkinson’s Disease, and its approval could provide a significant treatment option for patients.

When did Supernus Pharmaceuticals resubmit their NDA for SPN-830?

Supernus Pharmaceuticals resubmitted the NDA for SPN-830 on December 8, 2021.

What feedback did the FDA provide regarding the initial NDA submission for SPN-830?

The FDA issued a Refusal to File (RTF) letter in November 2020, indicating that the NDA was incomplete for substantive review.

What does the resubmission of the NDA for SPN-830 mean for investors in Supernus Pharmaceuticals?

The resubmission indicates ongoing development efforts, but the uncertainty of FDA approval could affect investor sentiment and stock performance.

What are the potential risks associated with the SPN-830 resubmission for Supernus Pharmaceuticals?

Risks include the possibility of continued regulatory hurdles and delays in approval, which could impact the company's market opportunities and financial performance.