Positive Outcomes for PH15 Nasal Spray in Mitigating Mental Fatigue-Induced Psychomotor Impairment

A recent clinical trial has shown promising results for a nasal spray designed to combat the effects of sleep deprivation. The spray, known as PH15, was developed by Vistagen, a biopharmaceutical company specializing in treatments for psychiatric and neurological disorders. The Phase 2A pilot study revealed that PH15 significantly improved reaction times in participants who were sleep-deprived, outperforming both a placebo and caffeine.

The study was conducted in a randomized, double-blind, and placebo-controlled manner, with participants receiving either PH15, a placebo, or caffeine. The participants were subjected to sleep deprivation sessions, during which their reaction times were measured at various intervals throughout the night. The results indicated that PH15 not only improved reaction times compared to the placebo but also demonstrated superiority over caffeine, particularly during the late-night testing periods when fatigue was at its peak.

Importantly, PH15 was found to be safe and well-tolerated, with an adverse event profile that was similar to that of the placebo. This is a significant advantage over caffeine, which is known to cause side effects such as palpitations and dry mouth. The study's findings have bolstered Vistagen's confidence in PH15's potential as a novel treatment for enhancing psychomotor performance and possibly addressing cognitive impairments caused by mental fatigue.

Vistagen's CEO, Shawn Singh, highlighted the importance of this research, stating that numerous disorders can lead to debilitating sleep deprivation and mental fatigue. He emphasized the need for improved treatment options that offer a differentiated safety profile, without the potential for abuse or negative side effects. Vistagen is now looking forward to exploring PH15's potential as a transformative solution for individuals affected by such disorders.

The study was originally sponsored by Pherin Pharmaceuticals, which has since become a subsidiary of Vistagen. The results were accessed by Vistagen following its acquisition of Pherin in early 2023. PH15 is a synthetic pherine, a new class of drugs that are delivered intranasally and target specific neural circuits in the brain without systemic absorption. This unique mechanism of action offers the potential for rapid efficacy and a favorable safety profile.

Vistagen is committed to developing groundbreaking therapies for individuals affected by psychiatric and neurological disorders. The company's pipeline includes several pherine candidates, all of which have shown a favorable safety profile in clinical trials. Vistagen is currently evaluating the next steps for PH15's development and the necessary nonclinical program to support a U.S. Investigational New Drug application for further development in the U.S.

The forward-looking statements in the original press release, which discuss the potential of PH15 and Vistagen's drug candidates, are based on reasonable estimates and assumptions but are inherently uncertain. The actual results may differ materially from those projected due to various risks and uncertainties, including the challenges in the development and commercialization process. Vistagen's commitment to innovation in neuroscience remains strong, and the company continues to explore new avenues to improve the lives of those affected by psychiatric and neurological disorders.