Major Depressive Disorder
Depression is a serious medical illness and a global public health concern that can occur at any time over a person's life. While most people will experience a depressed mood at some point during their lifetime, major depressive disorder (MDD) is different. MDD is the chronic, pervasive feeling of utter unhappiness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death or suicide and attempts at suicide. Currently available FDA-approved medications available in the multi-billion-dollar global antidepressant market often fall far short of satisfying the unmet medical needs of millions suffering from the debilitating effects of depression.
Vistagen’s Innovation:
In a small randomized, double-blind, placebo-controlled exploratory Phase 2A clinical study in MDD conducted in Mexico City, at a 6.4 mcg dose, rapid-onset antidepressant effects were observed and sustained for 8 weeks (p=0.022). Peer-reviewed results of the study also showed itruvone was well-tolerated and did not cause psychological side effects or safety concerns that may be associated with ketamine-based therapy. With its rapid-onset pharmacology and favorable safety results observed in clinical studies completed to date, we believe itruvone has potential to be a new stand-alone treatment for MDD and several other depression disorders.
The FDA has granted Fast Track designation for itruvone as a potential treatment for MDD.
