Company intends to pursue 505(b)(2) regulatory pathway for novel topical formulation of ketamine for the treatment of PTSD
Miami, FL — February 2, 2023 — 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 accelerated approval through one of the FDA’s expedited drug approval programs, such as Breakthrough Therapy, pending the development of preliminary clinical evidence to support such designation.
NeuroDirect™ for Non-Systemic Delivery
Psycheceutical’s patented NeuroDirect™ 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, vomiting, and toxicity. NeuroDirect™ is designed to be administered through telehealth or at home instead of a clinical setting, greatly lowering the cost of care for each patient, ensuring that these life-saving treatments are cheap and available to anyone suffering from mental health disorders or central nervous system diseases.
About Psycheceutical Bioscience, Inc.
Psycheceutical Bioscience, Inc. is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and top minds in the psychedelic space, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availability and market volatility, (iii) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.
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