Vistagen: Data from PH-10 study allows Phase 2B development for MDD treatment

Vistagen announced favorable safety and tolerability data from its U.S. Phase 1 clinical trial of itruvone PH10 , the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder, MDD. Results from the U.S. Phase 1 study build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable Phase 2B development of itruvone in the U.S. as an innovative stand-alone rapid-onset product candidate for treatment of MDD. The U.S. Phase 1 study was a randomized, double-blind, placebo-controlled clinical 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.