Supernus Reports Promising Phase 2a Results for SPN-820 in Major Depressive Disorder

Supernus Pharmaceuticals, Inc., a company specializing in the development and commercialization of products for central nervous system (CNS) diseases, has announced results from its exploratory open-label Phase 2a clinical study of SPN-820. This study focused on adults suffering from major depressive disorder (MDD). The primary goals were to evaluate the safety and tolerability of SPN-820 administered at a dose of 2400 mg every three days, alongside current antidepressant treatments, and to observe the rapid onset of improvement in depressive symptoms.

The Phase 2a study involved 40 participants, 38 of whom completed the 10-day treatment regimen. Findings from the study highlighted significant and rapid improvements in depressive symptoms. Specifically, subjects experienced a mean reduction of 6.1 points in the Hamilton Depression Rating Scale-6 Items (HAM-D6) total score within two hours of administration, and a reduction of 9.6 points by the tenth day. Similarly, the Montgomery Åsberg Depression Rating Scale (MADRS) total score showed a mean improvement of 16.6 points at four hours and 22.9 points by day 10. Additionally, there was a notable decrease in suicidal ideation, dropping from 12.5% at the study's start to 2.6% by day 10.

SPN-820 demonstrated a favorable safety profile with a low incidence of adverse events (AEs). The discontinuation rate due to AEs was only 2.5%. The most common AEs related to the drug included headache, nausea, somnolence, and dizziness. Other observed AEs were cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral.

Jack Khattar, President and CEO of Supernus Pharmaceuticals, expressed optimism about the potential of SPN-820 as a new treatment option for depression, emphasizing its ability to rapidly alleviate symptoms without certain side effects. Khattar also noted that the company expects to complete enrollment for the Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression by November, with topline results anticipated in the first half of 2025.

SPN-820 is an innovative, orally administered small molecule designed to enhance synaptic function in the brain by modulating the mechanistic target of rapamycin complex 1 (mTORC1). This mechanism aims to rapidly induce antidepressant effects without the dissociative side effects often associated with other treatments. The ongoing Phase 2b study will further investigate the efficacy of SPN-820 in approximately 227 adult patients with treatment-resistant depression.

Supernus Pharmaceuticals' diverse portfolio includes approved therapies for various CNS disorders such as epilepsy, migraine, ADHD, and Parkinson's disease-related conditions. The company is also developing new treatments for a range of CNS disorders, including depression and epilepsy.

In summary, the Phase 2a study of SPN-820 has shown promising results, indicating rapid and substantial improvements in depressive symptoms with few adverse effects. These findings support the potential of SPN-820 as a novel treatment for major depressive disorder, and the company is progressing towards further validation through their ongoing Phase 2b study.