• A pre-clinical observational study published in Drug Development & Delivery found that more than 80% of patients experienced relief within minutes of applying NeuroDirect™ ketamine topical cream
• Patients indicated their thought processes were clearer and more focused, and were more keenly aware of surroundings

MIAMI, March 21, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. ("Psycheceutical" or the "Company") (OTC: BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced the publication of pre-clinical observational data that supports the potential of its NeuroDirect™ ketamine topical cream as a treatment for PTSD. The study was published in the March 2023 issue of Drug Development & Delivery.

The preliminary observational data indicates that the non-systemic topical cream could be more effective at treating PTSD symptoms than cur­rent ketamine treatment options, which utilize systemic delivery methods. Additionally, the study supports the Company’s belief that the topical cream approach would be more cost-effective than current ketamine therapy options.

"Administering ketamine with NeuroDirect drug delivery technology has shown observational promise in addressing undesirable side effects and providing therapeutic benefits," said Dr. Ronald Aung-Din, Clinical Advisor for Psycheceutical and inventor of the NeuroDirect™ delivery system. "We believe this technology has the potential to play a significant role in developing new life-saving treatments for PTSD and other mental health conditions by safely dosing psychedelic compounds."

Observational data was collected in a non-clinical setting from an outpa­tient Neurology and Neuropsychiatry prac­tice, examining 100 patients with intractable depression, anxiety, and other symptoms commonly associated with PTSD. Sub­jects were patients with long-term symptoms related to PTSD who had each tried numerous previous other treatments. The patient group was comprised of 61 females and 39 males, and the patients' ages ranged from 12 to 90 years.

Objective measures like the Hamilton Depression Scale and EEG tracings documented the patients' responses. Family members and other observers also noted additional benefits from the treatment.

The innovative, non-systemic delivery method is being designed to deliver compounds across the blood-brain barrier while bypassing the GI tract and liver. Patients indicated relief of PTSD symptoms within minutes after using NeuroDirect keta­mine applied as a topical cream on the back of the neck.

• Eight patients had NeuroDirect keta­mine applied during EEG recording. All exhibited EEG improvement 3-5 minutes after treatment.
• Within 8-10 minutes of topical drug application, patients noted discernible improvement in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such symptoms.
• Six patients studied before and after treat­ment with ketamine exhibited a reduction in HAM-D scores of 40, 22, 13, 11, and 7 points 15 minutes after ketamine application.
  

Psychogenic effects, such as hallucinations or dissociative phenomena, were not expressed as having been experienced by any patient–all patients reported feeling clear-headed, more focused, and more aware of their surroundings.

"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. "The observational data shows us that this novel delivery method could improve how psychedelic pharmaceutical drugs are developed, studied, and administered. We are committed to bringing NeuroDirect ketamine through the formal steps needed to achieve the needed regulatory approvals to be able to make this revolutionary medicine available."

NeuroDirect™ for Non-Systemic Delivery
Psycheceutical’s 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, and dizziness. NeuroDirect™ 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.

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 the top minds in the psychedelic industry, 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.

Forward-Looking Statements:

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.

Contact:

Kaia Roman, VP, Strategy & Communications
kaia.roman@psycheceutical.com