Supernus Resubmits NDA for Apomorphine Infusion Set SPN-830 | Your money


ROCKVILLE, Md., December 8, 2021 (GLOBE NEWSWIRE) – Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on the development and commercialization of products for the treatment of diseases of the central nervous system (CNS), has announced today 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 initial NDA submission for SPN-830, the United States Food and Drug Administration (FDA) issued a Refusal to Submit Letter (RTF) in November 2020 stating that the NDA was not sufficiently complete to permit a thorough examination. The FDA provided additional clarification regarding the content of the November 2020 RTF letter and resubmission requirements 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 new approach for PD patients,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals. “We believe that continuous subcutaneous infusion of apomorphine for the treatment of motor fluctuations (OFF episodes) may be an attractive alternative for patients seeking less invasive options.”

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company specializing in the development and commercialization of products for the treatment of diseases of the central nervous system (CNS).

Our diverse portfolio of neuroscience includes approved treatments for epilepsy, migraine, ADHD, hypomobility in PD, cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa therapy and Drug-induced extrapyramidal reactions in adult patients. We are developing a wide range of new CNS product candidates, including potential new treatments for hypomobility in PD, epilepsy, depression and other CNS disorders.

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Forward-looking statements

This press release contains 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 anticipated or potential future events which are based on the current expectations of management. These statements are subject to risks and uncertainties which 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, these risks and uncertainties include, without limitation, the Company’s ability to maintain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its business strategy; the implementation of the Company’s business strategy; the future financial performance of the Company and projected expenses; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net sales; the Company’s ability to market 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 research and product development activities, including the timing and progress of the Company’s clinical trials, and projected expenses; the Company’s ability to receive and timing of receipt of any regulatory approvals to develop and commercialize the Company’s product candidates, including SPN-830; the Company’s ability to protect its intellectual property and to operate its business without infringing the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, efficacy and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets likely to 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 market growth; the Company’s product formulations, patient needs and potential funding sources; the personnel requirements of the Company; and other risk factors set forth from time to time in documents filed by the Company with the Securities and Exchange Commission pursuant to section 13 or 15 (d) of the Securities Exchange Act of 1934, as amended. The Company does not undertake to update the information contained in this press release to reflect events or circumstances subsequent to the date hereof or to reflect the occurrence of anticipated or unforeseen events.


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


INVESTOR CONTACT Peter Vozzo ICR / Westwicke Office: (443) 213-0505 Mobile: (443) 377-4767 Email: [email protected]

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