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By Faith Ashmore, Benzinga
PsycheceuticalBioscience, Inc (OTCPK: BWVI) is a biotechnology company withpatented technology that says it aims to revolutionize the psychedelicmental health space and disrupt Big Pharma. The company is developinga topical cream administration of ketamine to allow the drug todirectly target the brain. This unique approach could help solve manyof the current issues in mental health treatment through a uniqueapproach.
1in 6 American adults has reported taking a psychiatric druglike antidepressants or sedatives. The most widely prescribed form ofantidepressant are selective serotonin reuptake inhibitors (SSRIs) andyou’re probably familiar with the household names. Prozac, Zoloft,and Lexapro are all examples of SSRIs and these types of drugs areprescribed for a wide range of mental health and psychiatricconditions like anxiety, depression, PTSD, and eating disorders.
While thesetherapies are generally safe, theside effects can take a considerable toll on patients . Somepatients experience insomnia, nausea, skin rashes and decreased sexualdesire. Patients have also reported developing a tolerance to SSRIsand needing to rotate to other drugs once the drug has lost itsefficacy.
However, SSRIs are not the only treatment. In the past fewyears, there has been a reignited conversation about the therapeuticbenefits of psychedelics – especially psilocybin and ketamine –for mental health conditions like PTSD, anxiety, and depression.
The increasedfunding, research, and attention on psychedelics as the next gold rushin mental healthcare has caught the eyes of patients, providers, andinvestors alike. Wall Street has been investing tens of millions ofdollars in companies that show promising therapies. For example, GilgameshPharmaceuticals Inc. and LusarisTherapeutics Inc. have announced capital raises of around $100million.
Theglobal psychedelic drug market is expected to grow at a compoundannual growth rate (CAGR) of 13.3% from 2022 to 2029 , and theFDA is expected to approve treatments using MDMA and psilocybin withinthe next few years. The growing acceptable and governmentalendorsements, an increasing prevalence of mental health disorders, andgrowing awareness of mental health are all contributing to the rise inpsychedelic treatments.
And for good reason, psychedelics are showing wild success inclinical trials to help patients who have not seen success with othertreatments like SSRIs. Speaking on one class of psychedelics, RolandGriffiths, Ph.D - foundingdirector of Johns Hopkins Center for Psychedelic and ConsciousnessResearch - shared, “Psilocybin not only produces significantand immediate effects, it also has a long duration, which suggeststhat it may be a uniquely useful new treatment for depression.Compared to standard antidepressants, which must be taken for longstretches of time, psilocybin has the potential to enduringly relievethe symptoms of depression with one or two treatments.”
However, one of themajor challenges of psychedelics is the modules of treatment. The vastmajority of studies and products being developed deliver the drugsthrough oral administration or IVs. Psychedelic therapy is not assimple as taking Zoloft daily at home, which puts a burden on bothpatients and providers. For example, someone who is licensed toadminister psychedelic therapy has to undergoup to 150 hours of instruction and in-person trainingsessions ; the patient has to go to outpatient facilities fortreatment and be monitored after receiving treatment. This drives upthe cost of treatments like ketamine infusion, which can be between $400and $2000 per infusion .
Another consideration is that intravenous (IV) ororal administration of psychedelic therapy like ketamine, psilocybin,and more have a plethora of side effects. Side effects such as nausea,headaches, dizziness, disorientation and confusion are common withoral and IV ketamine routes of administration. This is primarilybecause both forms of administration require the body to absorbthrough the bloodstream and digestive tract to receive positivebenefits in the brain and nervous system.
Additionally, if the dosage is even slightly high or the bodyhas an adverse reaction, patients can experience unwanted sideeffects. Ketamine,for example, is known for a specific and scary side effect nicknamedthe “k-hole.” . Although it's not a common side effectin clinical settings, the “k-hole” leaves users feelingdisassociated from themselves and their surroundings resulting inpanic or paranoia.
Psycheceutical Bioscience ReportsPioneering A New Psychedelic Drug With No Side Effects And No ClinicalAdministration Needed
Psycheceutical Bioscience is developing a new and uniquemode of administration that could revolutionize the psychedelic mentalhealth space. The company is developing a ketamine treatment that isadministered as a topical cream at the back of the neck, to allow thedrug to directly target the brain and bypass the GI tract and liver.This process is being designed to eliminate the hallucinogenic effectsof psychedelic drugs and significantly reduce the toxicity and adverseeffects of these compounds.
The company’s patented NeuroDirect™ is intendedto enable immediate and sustained delivery, safe dosage control, andconsistent results, while avoiding the systemic side effects ofpsychedelic compounds such as hallucinations, nausea, and dizziness.In other words, the company believes this mode of administration willpresent no risk of a “k-hole” side effect. The company isbeginning clinical trials to prove the technology.
The NeuroDirect™ketamine topical cream could address the unmet need for rapid reliefof PTSD symptoms within minutes and is designed to be administered athome instead of a clinical setting, which would greatly lower the costof care for both insurance companies and patients, and increase accessto these life-saving treatments for anyone suffering from mentalhealth disorders or central nervous system diseases.
The majority of PTSDpatients, unfortunately, cannot rely on one single drug to help managetheir condition and oftentimes are on a cocktail of differentprescriptions. With the company’s NeuroDirect™ therapy, thecompany is seeking to make PTSD treatment simple and effective forpatients who have been struggling with no simple, safe, andcost-effective treatment available.
A peer-reviewed study published by Drug Development & Delivery shared that more than 80% of100 patients that tried NeuroDirect™ topical ketamine in apre-clinical study found it effective and no patients experiencedpsychogenic effects like hallucinations. In fact, patients felt morefocused and that their thought processes were clearer, one patienteven described the treatment as “[A] truth serum! I became aware ofthoughts and emotions I had suppressed which needed to come out”.The results were experienced within 8-10 minutes and lasted 4-6hours.
Psycheceutical Bioscience could be the next innovator in thedevelopment of pharmaceutical products for the mental health carespace. Esepcially for people who have not found success in othertreatments or are higher-risk patients, like children and the elderly,this module of psychedelic treatment might prove to be ideal.
Visit www.psycheceutical.com for more information on the company and its product candidates.
This article was originally published 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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