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. According to the World Health Organization, depression is the leading cause of disability worldwide, affecting over 250 million people. Statistics reported by the U.S. National Institute of Health indicate that approximately 21 million adults in the U.S., or approximately 8.4% of all adults in the U.S., had at least one major depressive episode in 2020. 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.
In a peer-reviewed, published exploratory Phase 2A clinical study in MDD conducted in Mexico City, at a 6.4μg dose, itruvone demonstrated significant (p=0.022) rapid-onset antidepressant effects which were sustained over an 8-week period, as measured by the Hamilton Depression Rating Scale-17 (HAM-D-17),without side effects or safety concerns that may be caused by certain oral antidepressants or intravenous or intranasal ketamine-based therapy. With its rapid-onset pharmacology and favorable safety results observed in clinical studies completed to date, Vistagen believes itruvone has potential to be a new stand-alone treatment for MDD and several other depression disorders.
Vistagen recently completed a randomized, double-blind, placebo-controlled U.S. Phase 1 study investigating the safety and tolerability of a single dose and of multiple doses of itruvone nasal spray in healthy adult subjects. There were no reported serious adverse events (SAEs) or discontinuations due to adverse events (AEs) in the study. Two AEs were reported during the treatment period, fatigue and headache, which occurred in the same subject. Both AEs were mild in severity and resolved without sequelae. Overall, itruvone nasal spray was well-tolerated and demonstrated a favorable safety profile, consistent with the three prior clinical studies of itruvone, including a positive randomized, double-blind, placebo-controlled Phase 2A study in MDD.
The completed successful U.S. Phase 1 study enables Vistagen’s plans for Phase 2B development of itruvone in the U.S. as a fast-acting stand-alone treatment for MDD.
The FDA has granted Fast Track designation for itruvone as a potential treatment for MDD.