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By Julian Richard, Benzinga
When the average personthinks about psychedelics, it is easy to conjure up a picture of atrippy experience with hallucinogenic visions, and ‘Lucy In The SkyWith Diamonds’ playing in the background. And if you aren’tfamiliar with the nuanced discussions that have recently arisen aroundthe use of psychedelics for mental health treatment, you’d be right.
Psychedelics are psychoactive substances that change mood, perception and cognitive processes. Whilepsychedelics have a rich history as part of healing ceremonies,especially in indigenous communities, the popular culture connotationsassociated with psychedelics are firmly planted in getting high.
However, in thepast few years, there has been a reignited conversation about thetherapeutic benefits of psychedelics – especially psilocybin andketamine – for mental health conditions like PTSD, anxiety anddepression.
Thevast majority of studies and products being developed deliver thedrugs through oral administration or IVs. While effective, thesemethods of administration also have a plethora of side effects. Someof the methods of administration require professional observation,which is time-consuming for patients who have to frequent clinics foreffective treatment.
Side effects such as nausea, headaches, dizziness,disorientation, and confusion are common with oral and IV ketamineroutes of administration. This is primarily because both forms ofadministration require the body to absorb through the bloodstream anddigestive tract to receive positive benefits in the brain and nervoussystem.
Additionally, if the dosage is even slightly high or the bodyhas an adverse reaction, patients can experience what is described asa "psychedelic" effect. Ketamine, for example, is known for a specific and scary side effectnicknamed the “k-hole.” Although it's not a commonside effect in clinical settings, the “k-hole” leaves usersfeeling disassociated from themselves and their surroundings resultingin panic or paranoia.
Psycheceutical Bioscience, Inc (OTCPK: BWVI) is abiotechnology company developing a new and unique mode ofadministration that is revolutionizing the psychedelic mental healthspace. The company is developing topical administration of ketaminewhich allows the drug to directly target the brain and bypass the gutand liver. This process eliminates the hallucinogenic effects ofpsychedelic drugs and significantly reduces the toxicity and adverseeffects of these compounds.
The proprietary patented NeuroDirect™non-systemic delivery technology system allows for immediate,consistent, safe, and sustained delivery of neuro-active compoundsdirectly to the nervous system. In other words, there is no risk of a“ k-hole” side effect. The NeuroDirect™ Ketamine TopicalDelivery System addresses the unmet need for rapid relief of PTSDsymptoms within minutes without the requirement to be supervised inthe home or spend hours in the clinic and without the side effectsassociated with oral or IV administration.
Topical administration may be an ideal optionfor patients who fall into higher-risk categories like teenagers,elderly individuals, or people who have experienced previous bad tripsand are weary of IV or oral administration. Currently, nothing likethis exists in the medical world; Psycheceutical Bioscience is trulyan innovator in the mental health care space.
PsycheceuticalBioscience has successfullycompleted its pre-Investigational New Drug (IND) meeting withthe U.S. Food and Drug Administration (FDA), which provided positivefeedback on the development plans for NeuroDirect™ Ketamine TopicalDelivery System for the treatment of post-traumatic stress disorder(PTSD).
Psycheceutical Bioscience is also partnering with theAustralian contract research organization iNGEN? Pty Ltd.("iNGEN?") to evaluate Psycheceutical’s patentedNeuroDirect™ Ketamine Topical Delivery System in Australianearly-phase clinical studies.
The Phase 1 study will be the first-in-human studyevaluating the safety, tolerability, and pharmacokinetics of TheNeuroDirect™ Ketamine Topical Delivery System in 20 healthyvolunteers. The subsequent phase 2a study will be conducted on 115individuals with PTSD and will evaluate the impact of treatment onsymptoms of the condition. The phase 2 study has been designed toremove the requirement of a phase 2b trial and, if recognized by theFDA as a “pivotal” study, will allow NeuroDirect™ to proceeddirectly to phase 3 research.
CEO of Psycheceutical, Chad Harman, shares,“We’ve developed a topical application to give people immediaterelief and most patients would rather use a topical cream than needlesor pills that affect the digestive system. With NeuroDirect™ketamine, there’s no need to spend multiple hours in a clinic orbeing supervised at home. NeuroDirect ketamine opens up the benefitsof psychedelic compounds to a much greater population, includingchildren, the elderly, and people who don’t have the time, money, ordesire to have a full-on psychedelic experience in a clinic or aretreat. Our goal is to remove the barriers and greatly increaseaccess to the benefits of ketamine for everyone suffering fromPTSD.”
Psycheceutial has taken a decisivestep forward in PTSD treatment by submitting an applicationfor the first-ever ketamine topical for provisional United StatesPatent and Trademark Office. The provisional patent application wouldbring the topically-applied ketamine formulations and their associatedmethods in treating PTSD, to the greater global market.
“PTSD can be a seriousmental health disorder, with no known effective therapeutic solutionscurrently available. Millions of people suffer each year,” said ChadHarman, CEO of Psycheceutical. “But there is new hope. This patentapplication supports Psycheceutical's ongoing drug developmentplans for its revolutionary NeuroDirect™ topical delivery system,that we believe has the potential to provide new solutions andtreatments for PTSD and other mental health conditions.”
The future may lookquite promising for NeuroDirect™ with their novel topical ketamineadministration. With clear guidance from the FDA on the clinical trialprogram, IND filing is anticipated by the end of 2023. Bypassing theneed to conduct a phase 2b study would accelerate the pathway to FDAapproval. Collaboration with Australian contract research organizationiNGEN? Pty Ltd. ("iNGEN?") will facilitate expedited patientaccess through favorable incentives offered by the Australian federalgovernment, namely the ability to register an FDA clinical trialbefore opening an investigational new drug application and the rapidinitiation of clinical trials.
Mental health conditions like PTSD and depressioncan be truly debilitating and life-threatening. The promise of atopically administered drug that decreases negative side effects, cutscosts and creates a better patient experience could be a game changerfor health providers and patients alike.
Visit www.psycheceutical.com for more information on the company and its product candidates.
This article originally appeared onBenzinga here .
PsycheceuticalBioscience, Inc. is developing cutting-edge technologies to advancethe safe and effective delivery of psychedelic pharmaceuticalmedicines. 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 dosingtechnologies to provide affordable, life-saving treatments to anyonesuffering from mental health disorders or central nervous systemdiseases.
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