By Faith Ashmore, Benzinga
Psycheceutical Bioscience, Inc (OTCPK: BWVI) is a biotechnology company with patented technology that says it aims to revolutionize the psychedelic mental health space and disrupt Big Pharma. The company is developing a topical cream administration of ketamine to allow the drug to directly target the brain. This unique approach could help solve many of the current issues in mental health treatment through a unique approach.
1 in 6 American adults has reported taking a psychiatric drug like antidepressants or sedatives. The most widely prescribed form of antidepressant are selective serotonin reuptake inhibitors (SSRIs) and you’re probably familiar with the household names. Prozac, Zoloft, and Lexapro are all examples of SSRIs and these types of drugs are prescribed for a wide range of mental health and psychiatric conditions like anxiety, depression, PTSD, and eating disorders.
While these therapies are generally safe, the side effects can take a considerable toll on patients. Some patients experience insomnia, nausea, skin rashes and decreased sexual desire. Patients have also reported developing a tolerance to SSRIs and needing to rotate to other drugs once the drug has lost its efficacy.
However, SSRIs are not the only treatment. 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 increased funding, research, and attention on psychedelics as the next gold rush in mental healthcare has caught the eyes of patients, providers, and investors alike. Wall Street has been investing tens of millions of dollars in companies that show promising therapies. For example, Gilgamesh Pharmaceuticals Inc. and Lusaris Therapeutics Inc. have announced capital raises of around $100 million.
The global psychedelic drug market is expected to grow at a compound annual growth rate (CAGR) of 13.3% from 2022 to 2029, and the FDA is expected to approve treatments using MDMA and psilocybin within the next few years. The growing acceptable and governmental endorsements, an increasing prevalence of mental health disorders, and growing awareness of mental health are all contributing to the rise in psychedelic treatments.
And for good reason, psychedelics are showing wild success in clinical trials to help patients who have not seen success with other treatments like SSRIs. Speaking on one class of psychedelics, Roland Griffiths, Ph.D - founding director of Johns Hopkins Center for Psychedelic and Consciousness Research - shared, “Psilocybin not only produces significant and immediate effects, it also has a long duration, which suggests that it may be a uniquely useful new treatment for depression. Compared to standard antidepressants, which must be taken for long stretches of time, psilocybin has the potential to enduringly relieve the symptoms of depression with one or two treatments.”
However, one of the major challenges of psychedelics is the modules of treatment. The vast majority of studies and products being developed deliver the drugs through oral administration or IVs. Psychedelic therapy is not as simple as taking Zoloft daily at home, which puts a burden on both patients and providers. For example, someone who is licensed to administer psychedelic therapy has to undergo up to 150 hours of instruction and in-person training sessions; the patient has to go to outpatient facilities for treatment and be monitored after receiving treatment. This drives up the cost of treatments like ketamine infusion, which can be between $400 and $2000 per infusion.
Another consideration is that intravenous (IV) or oral 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 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 unwanted side effects. 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 Reports Pioneering A New Psychedelic Drug With No Side Effects And No Clinical Administration Needed
Psycheceutical Bioscience is developing a new and unique mode of administration that could revolutionize the psychedelic mental health space. The company is developing a ketamine treatment that is administered as a topical cream at the back of the neck, to allow the drug to directly target the brain and bypass the GI tract and liver. This process is being designed to eliminate the hallucinogenic effects of psychedelic drugs and significantly reduce the toxicity and adverse effects of these compounds.
The company’s patented NeuroDirect™ 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. In other words, the company believes this mode of administration will present no risk of a “k-hole” side effect. The company is beginning clinical trials to prove the technology.
The NeuroDirect™ ketamine topical cream could address the unmet need for rapid relief of PTSD symptoms within minutes and is designed to be administered at home instead of a clinical setting, which would greatly lower the cost of care for both insurance companies and patients, and increase access to these life-saving treatments for anyone suffering from mental health disorders or central nervous system diseases.
The majority of PTSD patients, unfortunately, cannot rely on one single drug to help manage their condition and oftentimes are on a cocktail of different prescriptions. With the company’s NeuroDirect™ therapy, the company is seeking to make PTSD treatment simple and effective for patients who have been struggling with no simple, safe, and cost-effective treatment available.
A peer-reviewed study published by Drug Development & Delivery shared that more than 80% of 100 patients that tried NeuroDirect™ topical ketamine in a pre-clinical study found it effective and no patients experienced psychogenic effects like hallucinations. In fact, patients felt more focused and that their thought processes were clearer, one patient even described the treatment as “[A] truth serum! I became aware of thoughts and emotions I had suppressed which needed to come out”. The results were experienced within 8-10 minutes and lasted 4-6 hours.
Psycheceutical Bioscience could be the next innovator in the development of pharmaceutical products for the mental health care space. Esepcially for people who have not found success in other treatments 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 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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