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Phase 2 Clinical Trial Planned for Depression Drug

Rexahn Pharmaceuticals Inc., a clinical stage pharmaceutical company in Rockville, Maryland, submitted today a Phase 2b protocol to the U.S. Food and Drug Administration for the clinical study of Serdaxin, a drug that treats major depressive disorder.

The company says Serdaxin may work as an enhancer of serotonin and dopamine in the brain. In Rexahn’s proof of concept study, Serdaxin showed numerical differences versus a placebo for response and remission rates, as well as statistical significance in the severe patient population versus a placebo. The trial also demonstrated Serdaxin to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressants.

This clinical study will assess Serdaxin’s efficacy as a treatment for major depressive disorder in approximately 300 subjects.  The planned double blind, randomized, placebo-controlled trial will be conducted at multiple sites in the U.S. and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary measure of efficacy.

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