A new drug slated to undergo clinical study for major depressive disorder (MDD) shows promise for delivering the needed therapeutic effect to patients without triggering some of the more common side effects associated with anti-depressants.
Serdaxin has been submitted under a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for clinical study in the treatment of MDD. The drug is the lead CNS therapeutic currently being developed by Rexahn Pharmaceuticals, a clinical stage pharmaceutical company that targets the development of oncology and CNS therapeutics.
Specifically, the drug provides a unique method of action that works as a dual enhancer of serotonin and dopamine in the brain. A previously-completed PhaseIIa proof of concept study revealed promise for Serdaxin’s ability to effectively treat people with major depressive disorder when compared to placebo with a notable significance in severe cases.
The previous trial also demonstrated that patients tolerated the drug well without common side effects, which have been associated with all kinds of drugs used to treat depression including selective serotonin reuptake inhibitors (SSRIs), atypical antidepressants, tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
They Mayo Clinic lists the most common side effects of anti-depressants as nausea, increased appetite resulting in weight gain, fatigue, insomnia, sexual problems, dry mouth, dizziness, blurred vision, constipation and anxiety. Many patients make the choice to discontinue use of anti-depressants due to side effects, according to experts.
Aside from the PhaseIIa trial, Serdaxin has also demonstrated neuroprotective effectiveness in animals treated with neurotoxins. Further study could lend to treatment applications in such human disorders as Parkinson’s disease and Alzheimers.
The animal studies also revealed promise that the drug could be effective in treating aggressive behavior and anxiety.
Approximately 300 patients will participate in the PhaseIIb study to continue assessment of Serdaxin’s effectiveness and safety. The research will be comprised of a double-blind, randomized trial with controlled placebo and will be conducted at numerous sites in the U.S.
The drug’s efficacy will be measured by the change from baseline using the Montgomery-Asberg Depression Rating Scale (MADRS).
“We look forward to starting this PhaseIIb 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,” said Dr. Chang Ahn, Rexahn’s Chief Executive Officer.
A scientific advisory board was recently established by Rexahn for collaboration purposes and is composed of leading opinion leaders from across the globe who participate in research surrounding the treatment of depression.
Advisory Board Chairman Dr. Michael Thase said, “In my opinion, Serdaxin’s novel mechanism, which targets both serotonin and dopamine, coupled with the promising results of the recent proof of concept study, provide strong support for further clinical development of this well tolerated drug for treatment of depression.”
Thase is professor of psychiatry and the chief of the division of mood and anxiety disorders treatment and research program at the University of Pennsylvania.
Source: Rexahn Pharmaceuticals, Inc.