Business
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD.
About this update from Blue Water Ventures International, Inc.
[{"type":"text","content":"\n MIAMI, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) (\"Psycheceutical\" or the \"Company\"), a bioscience company dedicated to developing cutting-edge brain delivery technologies for the next generation of mental health treatments, is pleased to announce it has completed its pre-Investigational New Drug (\"IND\") meeting with the U.S. Food and Drug Administration (FDA) and received positive feedback regarding the Company's development plans for a novel NeuroDirect™ topical formulation of ketamine, intended for treating post-traumatic stress disorder (PTSD). The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies. In 2023, Psycheceutical remains focused on completing the remaining IND-enabling studies that will support the IND submission and transition into Phase I and Phase II clinical studies. \"We are undergoing a mental health epidemic, with millions suffering from conditions like PTSD with no current therapeutics on the market to help. We believe that NeuroDirect™ ketamine has the potential to be a life-altering treatment option that will provide profound benefits and relief to patients suffering from PTSD,” said Chad Harman, CEO of Psycheceutical. \"We thank the FDA for the constructive guidance during our pre-IND meeting. The constructive feedback and direction will allow us to be efficient and systematic towards safely transitioning our novel topical treatment from preclinical studies into a full clinical evaluation.\" In written responses to the questions provided by Psycheceutical, the FDA provided guidance on inquiries related to manufacturing, safety/toxicology, pre-clinical efficacy studies, clinical trial design, and the rationale necessary to support subsequent human clinical trials. This feedback supports Psycheceutical with greater clarity on the current requirements needed to file an acceptable IND to initiate Phase I and II clinical trials of NeuroDirect™ ketamine.Based upon the historical clinical data for ketamine and the Company's preclinical testing planned for NeuroDirect™ ketamine in 2023, the Company anticipates filing an IND by the end of 2023. In addition, Psycheceutical intends to pursue accelerate...