GlobeNewswire Inc | Feb 8, 2021 09:00AM EST

February 08, 2021

ROCKVILLE, Md., Feb. 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 SPN-812 for the treatment of ADHD in pediatric patients. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the NDA in November 2020 indicating that the review cycle for the application was incomplete and that the application was not ready for approval in its present form. Supernus and the FDA held a Type A meeting in January 2021 to discuss the CRL and the requirements for the NDA resubmission.

The primary issue cited in the SPN-812 CRL relates to the Companys in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus removed reference to its in-house laboratory and addressed other contents of the CRL.

The FDA will classify the NDA resubmission as Class I or Class II upon acceptance of the resubmission. Generally, a Class I review constitutes a two-month review from the date of resubmission and a Class II review constitutes a six-month review from the date of resubmission.

In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA to the FDA for SPN-812 in adults in the second half of 2021, assuming approval for pediatric patients.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. 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, hypomobility in Parkinsons Disease, cervical dystonia and chronic sialorrhea. We are committed to developing a broad range of novel CNS product candidates to address high unmet medical needs. Our development programs include new potential treatments for attention-deficit hyperactivity disorder, hypomobility in Parkinsons Disease, epilepsy, depression, and rare CNS disorders. For more information, please visit https://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. These forward-looking statements include expectations regarding the Companys recent and future interactions and communications with the FDA, the potential approval of the NDA for SPN-812 following resubmission, the planned submission of an sNDA to the FDA for SPN-812 in adults and the potential benefits and commercialization of SPN-812. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Companys ability to sustain and increase its profitability; the Companys ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Companys corporate strategy; the Companys future financial performance and projected expenditures; the Companys product research and development activities, including the timing and progress of the Companys clinical trials, and projected expenditures; the Companys ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Companys product candidates; the Companys ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Companys expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Companys product candidates; the accuracy of the Companys estimates of the size and characteristics of the markets that may be addressed by its products and product candidates; the Companys ability to increase its manufacturing capabilities for its products and product candidates; the Companys projected markets and growth in markets; the Companys product formulations and patient needs; potential funding sources; the Companys staffing needs; and other risk factors set forth from time to time in the Companys 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 Chief Executive Officer Jim Kelly, EVP & Chief Financial OfficerSupernus Pharmaceuticals, Inc.Tel: (301) 838-2591

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INVESTOR CONTACT:Peter VozzoWestwicke/ICROffice: (443) 213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com