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Rexahn Pharmaceuticals (RNN) Submits Phase IIb Protocol to FDA for Major Depressive Disorder Treatment

Rexahn Pharmaceuticals Inc., a clinical stage company focused on developing and commercializing oncology and CNS therapeutics, has submitted a phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin to assess the drug’s efficacy as treatment for major depressive disorder (MDD).

The double blind, randomized, placebo-controlled trial will involve approximately 300 subjects, and will be conducted at multiple sites in the U.S. The study will measure the change from the baseline, with the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.

In Rexahn’s phase IIa proof of concept study, Serdaxin demonstrated differences when compared to a placebo for response and remission, and also showed significance difference in the severe patient population versus placebo.

Rexahn CEO Dr. Chang Ahn said the phase IIb study will demonstrate Serdaxin’s efficacy compared to similar drugs currently in the market.

“We look forward to starting this phase IIb clinical trial and further investigating how Serdaxin’s novel action as a dual serotonin and dopamine enhancer may be able to provide a broader therapeutic effect with fewer side effects compared to currently marketed antidepressants,” Dr. Ahn stated in the press release.

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