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First Patient Dosed in Psycheceutical's Phase I Study Exploring Topical Administration of Ketamine to Treat PTSD
First Patient Dosed in Psycheceutical's Phase I Study Exploring Topical Administration of Ketamine to Treat PTSD.
About this update from Blue Water Ventures International, Inc.
[{"type":"text","content":"Psycheceutical's clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder through the company's NeuroDirect™ delivery system.MIAMI, FL / ACCESSWIRE / July 13, 2023 / Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC PINK:BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced that the first patient has been dosed in its Phase I study to evaluate its patented NeuroDirect™ ketamine topical delivery system for the treatment of Post Traumatic Stress Disorder (PTSD). NeuroDirect ketamine is the company's first non-systemic drug candidate designed to target free nerve endings on the back of the neck, with the objective of delivering psychedelic medicines safely, effectively and without hallucinogenic effects.The goal of the Phase I study, which is being conducted by iNGENū Pty Ltd. in Australia, is to test the safety, tolerability, and pharmacokinetics of NeuroDirect ketamine in 24 healthy adult volunteers. Psycheceutical's clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder."Today's achievement marks our transition to a clinical-stage company and represents an important milestone for Psycheceutical, and more importantly for those individuals who seek a safe, alternative therapy to improve their mental health," said Chad Harman, CEO of Psycheceutical. "With our goal of a non-systemic treatment for PTSD using legal ketamine, we are attempting to pave the way for our future drug candidates to treat other mental health disorders."The Phase I clinical trial builds on the recent positive results of a observational preclinical study published in Drug Development and Delivery that describes the potential of NeuroDirect ketamine topical cream as an improved treatment for PTSD. In the study of 100 patients who hadn't responded to traditional therapies, more than 80% trying NeuroDirect ketamine topical found it effective at treating their symptoms. As described in the study, "Discernible improvement[s] in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such s...