By Julian Richard, Benzinga
When the average person thinks about psychedelics, it is easy to conjure up a picture of a trippy experience with hallucinogenic visions, and ‘Lucy In The Sky With Diamonds’ playing in the background. And if you aren’t familiar with the nuanced discussions that have recently arisen around the use of psychedelics for mental health treatment, you’d be right.
Psychedelics are psychoactive substances that change mood, perception and cognitive processes. While psychedelics have a rich history as part of healing ceremonies, especially in indigenous communities, the popular culture connotations associated with psychedelics are firmly planted in getting high.
However, in the past few years, there has been a reignited conversation about the therapeutic benefits of psychedelics – especially psilocybin and ketamine – for mental health conditions like PTSD, anxiety and depression.
The vast majority of studies and products being developed deliver the drugs through oral administration or IVs. While effective, these methods of administration also have a plethora of side effects. Some of the methods of administration require professional observation, which is time-consuming for patients who have to frequent clinics for effective treatment.
Side effects such as nausea, headaches, dizziness, disorientation, and confusion are common with oral and IV ketamine routes of administration. This is primarily because both forms of administration require the body to absorb through the bloodstream and digestive tract to receive positive benefits in the brain and nervous system.
Additionally, if the dosage is even slightly high or the body has an adverse reaction, patients can experience what is described as a "psychedelic" effect. Ketamine, for example, is known for a specific and scary side effect nicknamed the “k-hole.” Although it's not a common side effect in clinical settings, the “k-hole” leaves users feeling disassociated from themselves and their surroundings resulting in panic or paranoia.
Psycheceutical Bioscience, Inc (OTCPK: BWVI) is a biotechnology company developing a new and unique mode of administration that is revolutionizing the psychedelic mental health space. The company is developing topical administration of ketamine which allows the drug to directly target the brain and bypass the gut and liver. This process eliminates the hallucinogenic effects of psychedelic drugs and significantly reduces the toxicity and adverse effects of these compounds.
The proprietary patented NeuroDirect™ non-systemic delivery technology system allows for immediate, consistent, safe, and sustained delivery of neuro-active compounds directly to the nervous system. In other words, there is no risk of a “ k-hole” side effect. The NeuroDirect™ Ketamine Topical Delivery System addresses the unmet need for rapid relief of PTSD symptoms within minutes without the requirement to be supervised in the home or spend hours in the clinic and without the side effects associated with oral or IV administration.
Topical administration may be an ideal option for patients who fall into higher-risk categories like teenagers, elderly individuals, or people who have experienced previous bad trips and are weary of IV or oral administration. Currently, nothing like this exists in the medical world; Psycheceutical Bioscience is truly an innovator in the mental health care space.
Psycheceutical Bioscience has successfully completed its pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), which provided positive feedback on the development plans for NeuroDirect™ Ketamine Topical Delivery System for the treatment of post-traumatic stress disorder (PTSD).
Psycheceutical Bioscience is also partnering with the Australian contract research organization iNGENū Pty Ltd. ("iNGENū") to evaluate Psycheceutical’s patented NeuroDirect™ Ketamine Topical Delivery System in Australian early-phase clinical studies.
The Phase 1 study will be the first-in-human study evaluating the safety, tolerability, and pharmacokinetics of The NeuroDirect™ Ketamine Topical Delivery System in 20 healthy volunteers. The subsequent phase 2a study will be conducted on 115 individuals with PTSD and will evaluate the impact of treatment on symptoms of the condition. The phase 2 study has been designed to remove the requirement of a phase 2b trial and, if recognized by the FDA as a “pivotal” study, will allow NeuroDirect™ to proceed directly to phase 3 research.
CEO of Psycheceutical, Chad Harman, shares, “We’ve developed a topical application to give people immediate relief and most patients would rather use a topical cream than needles or pills that affect the digestive system. With NeuroDirect™ ketamine, there’s no need to spend multiple hours in a clinic or being supervised at home. NeuroDirect ketamine opens up the benefits of psychedelic compounds to a much greater population, including children, the elderly, and people who don’t have the time, money, or desire to have a full-on psychedelic experience in a clinic or a retreat. Our goal is to remove the barriers and greatly increase access to the benefits of ketamine for everyone suffering from PTSD.”
Psycheceutial has taken a decisive step forward in PTSD treatment by submitting an application for the first-ever ketamine topical for provisional United States Patent and Trademark Office. The provisional patent application would bring the topically-applied ketamine formulations and their associated methods in treating PTSD, to the greater global market.
“PTSD can be a serious mental health disorder, with no known effective therapeutic solutions currently available. Millions of people suffer each year,” said Chad Harman, CEO of Psycheceutical. “But there is new hope. This patent application supports Psycheceutical's ongoing drug development plans for its revolutionary NeuroDirect™ topical delivery system, that we believe has the potential to provide new solutions and treatments for PTSD and other mental health conditions.”
The future may look quite promising for NeuroDirect™ with their novel topical ketamine administration. With clear guidance from the FDA on the clinical trial program, IND filing is anticipated by the end of 2023. Bypassing the need to conduct a phase 2b study would accelerate the pathway to FDA approval. Collaboration with Australian contract research organization iNGENū Pty Ltd. ("iNGENū") will facilitate expedited patient access through favorable incentives offered by the Australian federal government, namely the ability to register an FDA clinical trial before opening an investigational new drug application and the rapid initiation of clinical trials.
Mental health conditions like PTSD and depression can be truly debilitating and life-threatening. The promise of a topically administered drug that decreases negative side effects, cuts costs and creates a better patient experience could be a game changer for health providers and patients alike.
Visit www.psycheceutical.com for more information on the company and its product candidates.
This article originally appeared on Benzinga here.
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.
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