Vistagen has announced the results of a successful US Phase 1 study of Itruvone (PH10), which enables the drug's development for treating major depressive disorder. The U.S. Phase 1 clinical trial was a randomized, double-blind, placebo-controlled clinical study investigating the safety and tolerability of a single dose and multiple doses of itruvone nasal spray in healthy adult subjects. The positive results build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study previously conducted outside the US.
Itruvone, an investigational pherine nasal spray, is designed to engage and activate chemosensory neurons in the nasal passages connected to neural circuits in the brain that produce antidepressant effects. It does not require systemic uptake or brain penetration to produce rapid-onset of antidepressant effects unlike all currently approved oral antidepressants and rapid-onset ketamine-based therapy (KBT). The FDA has granted Fast Track designation for development of itruvone as a potential treatment for major depressive disorder.The confirmation of itruvone’s safety profile demonstrated in the U.S. Phase 1 study, along