Psycheceutical Bioscience, Inc. 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 iNGENu 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. 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 in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such symptoms were noted within 8-10 minutes of topical drug application. No psychogenic effects, such as hallucinations or dissociative phenomena, were experienced by any patient. To the contrary, patients indicated their thought processes were clearer, more focused, and that they were more keenly aware of surroundings. The global PTSD treatment market size was valued at $16.0 billion in 2021 and is projected to reach $26.1
billion by 2031, growing at a compound annual growth rate (CAGR) of 4.9% (Vikita et al., 2022). With millions of people around the world suffering from PTSD, and no effective therapeutics currently available, Psychceutical's hope is that NeuroDirect ketamine could revolutionize the PTSD treatment market. The company has already achieved important milestones in its push to commercialize its unique product, with initial discussions held with the U.S. Food and Drug Administration (FDA) where a 505(b)(2) pathway has been identified for obtaining regulatory approvals. Psycheceutical's NeuroDirectâ„¢ non-systemic delivery technology is designed to deliver neuro-active compounds
directly into the nerve tissue via topical application at the back of the neck. This delivery system is
intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding
the systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness. NeuroDirectâ„¢
is designed to be administered at home instead of a clinical setting, greatly lowering the cost of care for both
insurance companies and patients, increasing access to these life-saving treatments for anyone suffering from
mental health disorders or central nervous system diseases.