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SerdaxinTM is being developed to treat depression and mood disorders. SerdaxinTM is a dual enhancer of serotonin and dopamine levels in the brain. It has a mechanistic action unique from the widely used antidepressants called selective serotonin reuptake inhibitors (SSRIs or SNRIs). SerdaxinTM may effectively treat negative mood state and loss of positive mood state, and mixture of both mood states as well. Depression may result from excessively abnormal mood states such as negative mood state, loss of positive mood state or a mixture of both mood states. Leading treatments for depression are selective serotonin reuptake inhibitors (SSRIs or SNRIs). SSRIs/SNRIs may be effective in treating the negative mood state, but may not be effective in depression resulting from loss of positive mood state. The latter mood state may be more responsive to the dopaminergic therapy. Significant portions of patients have mixed symptoms of both these mood states, and thus show high lingering symptoms after remission and high relapse rate following the leading treatment. There are high unmet needs in treating depression, including the need for drugs with faster onset of action, greater efficacy, and minimum side effects. Among antidepressants, SSRIs/SNRIs appear to be the leading therapy, but are only partially effective and have a 50% estimated response rate and up to 30% relapse rate.
Research over the past 20 years has primarily focused on the role of serotonin in the pathophysiology and treatment of mood disorders and anxiety. It has been recognized that the serotonergic system is linked to the negative affect. However, recent findings indicate that dopamine plays an integral part in underlying pathophysiology as well as neurobiology of a number of highly, prevalent, chronic debilitating symptoms of anxiety and mood disorders. It is now recognized that the dopaminergic system is linked to loss of the positive affect such as loss of pleasure, loss of motivation, and loss of energy. Symptoms of mood disorders are causally related and clinical evidence identifying low level of dopamine in the brain and plasma of patients.
SerdaxinTM may possess greater efficacy and better tolerability compared with existing antidepressants. Studies to date indicate that SerdaxinTM has no motor impairment and cognition deficit of benzodiazepines, and no insomnia, weight gain, nausea and sexual dysfunction – potentially resulting in greater medication compliance. Of the disadvantages linked to SSRIs, SNRIs, and benzodiazepines, SerdaxinTM addresses most of the highest unmet needs by providing potentially faster onset of action, better and broader efficacy and fewer side effects.
SerdaxinTM may possess broader and greater therapeutic effects on depression by acting on both negative mood state and loss of positive mood states. These mood states appear to be affected by brain levels of the neurotransmitters serotonin and dopamine. The safety profile of SerdaxinTM, based on studies to date, is considered superior to current antidepressants. The extensive safety of SerdaxinTM may potentially lead to greater medication compliance among patients.
Potential targets of SerdaxinTM in the brain have been isolated and are being characterized through further studies. Functional Magnetic Resonance Imaging (fMRI) imaging of rat brains has shown that SerdaxinTM significantly increased activities in regions important for serotonin and dopamine actions. SerdaxinTM Phase IIa clinical trials have been successfully completed and planning for Phase IIb trials is underway. Multiple indications are possible, including potential use in anxiety and mood disorders, Parkinson's Disease and Alzheimer's Disease.
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