Supernus Announces Topline Results from Phase 2b Study in Adults with Treatment Resistant Depression

• Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo
• SPN-820 was well-tolerated with few adverse events, consistent with previously reported studies

ROCKVILLE, Md., Feb. 18, 2025 (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, announced today that the Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD) did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score to Week 4 (SPN-820 [LS mean ± Standard Error]: -12.3 ± 0.96 vs. placebo: -11.9 ± 0.96; p = not significant). There was no treatment difference between SPN-820 and placebo in the change from baseline to Week 4 for the secondary endpoints. The safety profile of SPN-820 was consistent with previous clinical trials, showing few adverse events.

“We are disappointed that the trial did not meet its primary endpoint in this patient population,” said Jack Khattar, President and CEO of Supernus. “We will continue to analyze these data and discuss the future of the program with our development partner, Navitor Pharmaceuticals. I’d like to thank the patients, coordinators and investigators, as well as the development team at Supernus, for their time and efforts in conducting this trial.”

About the SPN-820 Phase 2b Clinical Study

The Phase 2b study was a multi-center, randomized, double-blind, placebo-controlled trial of SPN-820 in adults with TRD. The study examined the efficacy and safety of SPN-820 over a course of four weeks of treatment and then a week of blinded placebo-washout in approximately 250 patients from approximately 40 clinical sites. The primary outcome measure was the change from baseline to end of treatment period on the MADRS Total Score.

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

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Forward-Looking Statements

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CONTACTS:

Jack A. Khattar, President and CEO

Timothy C. Dec, Senior Vice President and CFO

Supernus Pharmaceuticals, Inc.

(301) 838-2591

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INVESTOR CONTACT:

Peter Vozzo

ICR Healthcare

(443) 213-0505