US-based biopharmaceutical company Vistagen has reported favourable safety and tolerability results from a Phase I clinical trial of itruvone (PH10) nasal spray for the treatment of major depressive disorder (MDD).

The placebo-controlled study evaluated the tolerability and safety of one and multiple doses of its investigational, rapid-onset pherine nasal spray in healthy adults.

No serious adverse events or discontinuations due to adverse events were reported in the study.

One patient showed fatigue and headache during the treatment period, both of which were mild in severity and resolved with no long-term effects.

The study was initiated based on positive results from placebo-controlled Phase I and Phase IIA studies of itruvone, which were carried out in Mexico.

Patients in the Phase IIA trial were administered daily with a dose of 3.2μg and 6.4μg intranasally for eight weeks.

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By GlobalData

After one week of treatment, the Itruvone 6.4μg group showed a mean reduction of 10.1 points against placebo group of 4.2 points from baseline, as measured on the 17-item Hamilton Depression Scale (HAM-D-17).

This effect was sustained until the study’s endpoint at week eight.

Itruvone has been well-tolerated and demonstrated a favourable and consistent safety profile in each study.

Vistagen CEO Shawn Singh said: “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 I study in the US and a positive Phase IIa study conducted outside the US in hand, we look forward to advancing itruvone into Phase IIb development in the US, on our own or with a partner.”