Rexahn Pharmaceuticals, Inc. (AMEX: RNN), a leader in innovative therapeutics for life-threatening and life-debilitating diseases, recently announced that the company has received FDA approval to begin Phase II trials for Serdaxin™, for the treatment of major depressive disorders. Serdaxin is being developed as an orally administered, extended-release tablet for the treatment of depression and anxiety.
According to the World Health Organization, major depressive disorder is the leading cause of disability in the United States for ages 15 to 44. There are 154 million cases of depression reported worldwide each year, and this condition is nearly twice as prevalent in women as in men. Major depressive disorder is expected to become the second-leading cause of disability worldwide by the year 2020.
Serdaxin is a dual enhancer of serotonin and dopamine neurotransmitters. In preclinical studies, Serdaxin was shown to significantly improve an individual’s negative mood state and the loss of positive mood state, with the onset of action taking less than 48 hours. Serdaxin has shown no serious side effects, cognitive deficit or motor impairment. The Serdaxin Phase II trial is a randomized, double-blind, placebo-controlled parallel study for the treatment of major depressive disorders (MDD). It is a multi-center trial with preliminary data in humans expected in the second half of 2009.
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