Acute Treatment for Improvement of Cognition
PH15 is an investigational pherine nasal spray with a novel, rapid-onset potential mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments to improve cognitive impairment caused by mental fatigue and potentially other disorders. Early functional MRI studies in human volunteers at Stanford University revealed that intranasal administration of PH15 induced rapid activation of brain areas related to cognition1
In a small double blind, placebo-controlled study conducted at the National Institute of Psychiatry, Sleep Disorders Clinic, Mexico City, Mexico, in human subjects who were sleep deprived to induce mental fatigue, intranasal PH15 showed rapid and significant improvement in cognitive and psychomotor performance and improvement of reaction time that was better than the effect of a placebo and 400 mg of oral caffeine. PH15 was well-tolerated in this study and no serious adverse events were reported.
Vistagen is currently evaluating the path forward to submitting an U.S. IND for a Phase 2 clinical study, on its own or with collaborators, and the appropriate indication for demonstrating improvement of cognitive function.
1. Sobel et al, Brain, 1999
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