Vistagen said that a Phase 1 study of itruvone (PH10) nasal spray, which the company is developing for the treatment of major depressive disorder, found that itruvone was well tolerated with no serious adverse events. The company had announced the initiation of the study to evaluate a new formulation of PH10 in January 2023.
PH10 for the treatment of major depressive disorder was granted Fast Track designation by the FDA in December 2022. Vistagen licensed PH10 nasal spray from Pherin Pharmaceuticals in 2018 and recently acquired Pherin outright. Prior to licensing the nasal spray to Vistagen, Pherin had conducted Phase 1 and Phase 2a studies of PH10. Data from the Phase 2a trial were published in the British Journal of Pharmaceutical and Medical Research in 2019.
Vistagen CEO Shawn Singh commented, “According to a recent Gallup survey, more than a quarter of American adults have been diagnosed with depression at some point in their lifetime. The need for faster-acting, safer and more effective medications is unrelenting, especially in an environment where the gap between innovative treatment options and the prevalence of depressive disorders is increasing. With a successful Phase 1 study in the US and a positive Phase 2A study conducted outside the US in hand, we look forward to advancing itruvone into Phase 2B development in the US, on our own or with a partner.”
In addition to PH10, Vistagen is developing several other Pherin nasal sprays, including fasedienol (PH94B, aloradine) for the treatment of social anxiety disorder and PH80 (epoxyestrenolone) for the treatment of migraine and hot flashes.
Read the Vistagen press release.
