According to recent estimates, approximately 8 million adults in the United States alone experience PTSD in any given year. However, the condition has been historically difficult to treat and relief can be hard to come by.
Currently, antidepressants like SSRIs and SSNIs are prescribed as a first-line defense strategy for treating PTSD. However, studies have shown only 20% to 30% of patients achieve complete remission with these medicines.
Biotech company Psycheceutical is developing next-generation psychedelic delivery systems for individuals seeking safe, alternative treatment options to improve their mental health.
The company’s lead candidate is NeuroDirect, a ketamine topical delivery system designed to provide relief from PTSD symptoms while eliminating the side effects usually experienced with psychedelics.
We spoke with Chad Harman, CEO of Psycheceutical, to find out more about the novel treatment, stigma within the field and his hopes for psychedelic treatments moving forward.
BPR: Could you tell us about Psycheceutical Bioscience’s clinical trial program testing ketamine as a potential treatment?
The lead candidate in our drug development pipeline is our NeuroDirect ketamine topical for the treatment of PTSD. We’ve selected ketamine because it’s currently the only legal psychedelic compound in the U.S. The market size for PTSD treatment is over $16 billion per year and there are no known effective therapeutic solutions currently available.
Psycheceutical’s patented NeuroDirect non-systemic delivery technology is being developed to deliver neuroaffective compounds directly into the nervous system through topical application at the back of the neck. This delivery method is expected to act within minutes to enable immediate and consistent results – while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, dizziness, as well as toxicity to the liver and kidneys.
NeuroDirect is designed to be administered at home instead of a clinical setting, which could greatly lower the cost-of-care for both insurance companies and patients. By making psychedelic medicines safer and cheaper, those suffering from mental health disorders or nervous system diseases would potentially have greater access to these life-saving treatments.
BPR: So far, has your research found ketamine to alleviate the symptoms of PTSD?
Yes, NeuroDirect has already shown positive results in an observational preclinical setting. Dr. Ronald Aung-Din, Psycheceutical’s clinical advisor and inventor of the NeuroDirect delivery system, has been treating PTSD patients with his novel topical ketamine formulation for a number of years through his General Neurology and Neuropsychiatry practice, and currently has several hundred patients using it on a regular basis.
In addition, Dr. Aung-Din recently published a peer-reviewed study in Drug Development & Delivery which describes the potential of NeuroDirect ketamine topical cream as an improved treatment for PTSD. In 100 patients with intractable depression, anxiety, and other symptoms commonly associated with PTSD who had failed numerous other treatments, more than 80% experienced symptom relief from the NeuroDirect ketamine cream. No psychogenic or other deleterious systemic side effects were encountered.
The study states: “Discernible improvement[s] in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuropathic pain, and other such symptoms were noted within 8-10 minutes of topical drug application. No psychogenic effects, such as hallucinations or dissociative phenomena, were experienced by any patient. To the contrary, patients indicated their thought processes were clearer, more focused, and that they were more keenly aware of surroundings.”
BPR: How does the topical application of ketamine differ from older delivery methods such as capsules, IV and troches?
Older methods of delivering ketamine such as capsules, IV and sublingual troches all focus on systemic administration, meaning active drugs in your bloodstream that affect the whole body. Because your body metabolizes most of the drug through your kidneys and liver, high doses are required for target engagement and a desired effect. This leads to uncomfortable ‘trippy’ side effects like hallucinations, dizziness, nausea etc, and can also lead to toxicity in the liver and kidneys over time. Oral and sublingual methods can be unpredictable, with the onset of effects varying widely due to variable absorption in the digestive system. Additionally, IV administration requires medical supervision and is usually done in a clinical setting, which can be inconvenient and costly.
Topical ketamine was historically used for pain management by blocking NMDA receptors at the localized site of discomfort. This approach targets specific areas of pain without systemic side effects. Our goal is to take advantage of the non-systemic benefits of topical ketamine to rapidly relieve symptoms of psychiatric conditions as well.
BPR: How can ketamine be used without inducing hallucinations or psychedelic effects?
By avoiding the systemic administration of ketamine, we believe that our NeuroDirect topical method can alleviate the symptoms of mental health disorders without inducing psychedelic effects. Psycheceutical's NeuroDirect non-systemic delivery technology is designed to deliver neuroaffective compounds to directly affect the nervous system through topical application at the back of the neck.
Topical ketamine activates receptors on free nerve-endings under the skin surface at the critical location adjacent to brainstem structures. Neurochemical reactions are induced which result in nerve action potentials transmitted to the brain, producing therapeutic benefits without the restrictions of the blood-brain barrier (BBB). This drug delivery acts within minutes to allow therapeutic benefits while avoiding the usual systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness.
BPR: Do you have any concerns about the stigma surrounding ketamine? Or do you believe it is gaining credibility as a legitimate treatment?
There are certainly concerns about the stigma surrounding ketamine, which is primarily due to its history of recreational use and potential for abuse. Some people may view it as a party drug, rather than a legitimate form of treatment. This perception has created barriers to its acceptance in the medical community and among patients.
Despite this, ketamine is gaining credibility as a legitimate treatment for mental health conditions, including depression and PTSD. Currently, ketamine is being widely prescribed through clinics and telehealth across the U.S. to treat various mental health disorders. In a controlled environment, under the supervision of trained healthcare providers, ketamine administration can be a safe and effective treatment option for mental health disorders, including depression and PTSD.
Public opinion appears to be shifting as more research demonstrates the therapeutic benefits of ketamine. Also, medical professionals are working to dispel misconceptions and educate the public about its legitimate use. While stigma surrounding ketamine exists, it is increasingly being recognized as a valuable tool in treating mental health conditions. The key is to continue research, education, and dialogue to ensure its safe and effective use.
BPR: Do you believe ketamine has the potential to reshape the landscape of PTSD treatment moving forward?
Absolutely. One theory suggests that PTSD is a "synaptic disconnection syndrome", meaning that the connections between neurons in the brain are disrupted. Psychedelic drugs like ketamine may work by rapidly repairing the brain's synaptic connections–thereby promoting a brain status known as neuroplasticity, which may help to alleviate symptoms of PTSD.
As stated previously, our product is already in use through Dr. Aung-Din’s practice, and more than 80% of patients trying NeuroDirect ketamine topical found it effective at treating their symptoms, to the extent formal prescriptions were requested for continued use at home. It’s rare to have such promising observational preclinical data for a company at this stage in the clinical trial process.
Not everyone can afford expensive ketamine treatments, and a lot of people are uncomfortable with the thought of a “psychedelic experience.” By making a topical cream that’s safe, effective and non-hallucinogenic, we hope to legitimize ketamine as a treatment option for the general public. And in designing NeuroDirect ketamine to be administered at home instead of a clinical setting, we can greatly lower the cost-of-care for both insurance companies and patients, potentially increasing access to these life-saving treatments for anyone suffering from mental health or neurodegenerative disorders.
BPR: What are your ambitions for Psycheceutical Bioscience’s program moving forward? Where would you like the company to be in 5 years?
Psycheceutical is developing precision dosing technologies designed to evade restrictions of the blood-brain barrier (BBB) in order to safely deliver the next generation of therapeutic medicines effectively to the brain and nervous system. While our company is currently focused on psychedelic medicines to treat mental health disorders, we are in plans to expand our brain delivery technology towards traditional pharmaceutical medicines in order to treat neurodegenerative disorders like Parkinson’s, Alzheimers and Traumatic Brain Injury (TBI).
We are also moving forward with university partners to develop a revolutionary method to treat deadly cancers in the brain. In five years, we believe that Psycheceutical will be working with the world's largest pharmaceutical companies to provide accurate and safe dosing of psychedelic medicines for a number of mental health conditions. It is also our intention to have our own FDA-approved formulations delivered through our patented technologies.