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 280 million people.1 Statistics reported by the U.S. National Institute of Health indicate that approximately 21 million adults in the U.S., or approximately 8.3% of all adults in the U.S., had at least one major depressive episode in 2021.2 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.
Itruvone (PH10) is an odorless, tasteless synthetic investigational neuroactive pherine nasal spray with a mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders. Itruvone is administered at microgram-level doses and designed to engage and activate chemosensory neurons in the nasal cavity, which are connected to neural. circuits in the brain that produce antidepressant effects.
Vistagen recently completed a successful Phase 1 trial designed to confirm the favorable safety profile of itruvone established in three previous clinical trials conducted in Mexico, including a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone in MDD. These results facilitate potential Phase 2B clinical development of itruvone, in the U.S., by Vistagen or by a strategic development and commercialization partner, as a fast-acting monotherapy for MDD.
The FDA has granted Fast Track designation for itruvone as a potential treatment for MDD.
1. World Health Organization, March 2023
2. National Institute of Mental Health, July 2023