Psycheceutical
Pioneering the Future of Safe, Accessible, and Non-hallucinogenic Psychedelic Medicines

Mental health issues such as depression, anxiety, and post-traumatic stress disorder (PTSD) are on the rise. Traditional treatment methods include counseling, psychotherapy, medication, and support groups, with a focus on enhancing the quality of life for individuals. However, these treatments are not very successful in the long term due to the low effectiveness and side effects of current medications, as well as the individualized nature of each person’s disorder.

Thankfully, advancements in healthcare have resulted in a shift towards a new class of treatment using psychedelic medicines—compounds that can induce mind-altering states affecting perception, thought, and sensory input—which hold great potential in treating mental health issues more effectively. However, administering psychedelics orally or intravenously can present their own side effects such as hallucinations, paranoia, and psychosis. This underscores the pressing need for innovative solutions to administer psychedelics in a safer, more effective, and controlled manner.

Psycheceutical, Inc. is a pharmaceutical company focused on the development of innovative drug delivery systems for psychedelic compounds. The company aims to address the limitations associated with traditional methods of administering psychedelics by developing proprietary drug delivery systems that will remove the side effects and hallucinogenic experiences from established psychedelic molecules to allow for safe and controlled dosing.

With a focus on advancing next-generation brain-drug technologies, Psycheceutical is leveraging decades of clinical data to safely deliver well-established psychedelic compounds. The company’s primary strategic approach involves utilizing the FDA 505(b)(2) regulatory pathway for new drug applications (NDA). This pathway promises a more cost-effective and expedited route to approval, allowing Psycheceutical to create distinct and commercially valuable products. By concentrating on known psychedelic compounds delivered through innovative methods, the company aims to swiftly penetrate the market with its drug formulations that are designed to be not only safe but also affordable and accessible to a broad audience.

“Our next-generation technologies, which use systemic and non-systemic routes of administration, are designed to bypass the blood-brain barrier (BBB) to allow psychedelics to be administered without abuse potential, hallucinogenic side effects, or toxicity to the liver and kidneys,” says Chad Harman, President of Psycheceutical, Inc.

The company’s next-generation delivery systems are being developed to address the medical and technological limitations keeping psychedelic medicines from being safe, effective, and widely accessible. These technologies are designed to effectively bypass the blood-brain barrier, facilitating the direct delivery of psychedelic compounds to specific receptor sites in the brain within minutes, while circumventing the stomach and liver to minimize exposure to potential drug toxicities. Psycheceutical’s innovations are also intended to eliminate the hallucinogenic side effects traditionally associated with psychedelics. The user-friendly administration of these technologies at home instead of a clinical setting could significantly reduce the overall cost of care for insurance companies and patients.

Leveraging their innovative NeuroDirectTM technology, Psycheceutical is advancing its initial drug in the development pipeline—the non-systemic NeuroDirect ketamine topical, tailored specifically for PTSD treatment. This marks a pioneering endeavor, as Psycheceutical’s clinical trial program is the first to explore the topical application of ketamine for treating a mental health disorder. Selecting ketamine as the focal compound is strategic, given its distinct status as the sole legal psychedelic compound available in the market. Ketamine also boasts a well-established history in managing pain and neuropsychiatric disorders, adding a dimension of credibility and familiarity to Psycheceutical’s therapeutic ventures. The company’s versatile and innovative delivery method allows the self-administration of ketamine either at home or on-the-go using a convenient topical cream applied to the back of the neck at the hairline. This approach is expected to minimize complexities, enhance accessibility, and reduce the costs associated with clinical settings, presenting a transformative shift in ketamine therapy delivery.

A recent peer-reviewed study in Drug Development & Delivery by Dr. Ronald Aung-Din, Clinical Advisor of Psycheceutical and inventor of the non-systemic NeuroDirect delivery system, underscores NeuroDirect ketamine topical cream’s significant potential as an enhanced treatment for PTSD. The study, encompassing 100 patients grappling with intractable depression, anxiety, and PTSD-related symptoms resistant to previous treatments, revealed that over 80 percent experienced relief through the innovative NeuroDirect ketamine cream, marking a notable advancement in mental health care.

Patients using the NeuroDirect topical ketamine cream have shared impactful testimonials about their experiences. One patient described the ketamine cream as a ‘truth serum,’ expressing how it facilitated a newfound openness regarding traumatic details from her past and the defense mechanisms she had employed to cope. She demonstrated an impressive 11-point reduction on the Hamilton Depression Scale. In another case, a patient grappling with chronic alcoholism and a mood disorder underwent a remarkable mood transformation within three to five minutes of ketamine application. This swift change eliminated the patient’s desire to drink, leaving both the patient and their mother amazed at the immediate positive shift brought about by the topical ketamine treatment.

Currently in Phase 1 clinical trials in Australia, the company has achieved success with the completed dosing of the first cohort of patients, with key results showing the topical ketamine formulation to be safe and well-tolerated. This double-blind, placebo-controlled study involves 24 patients, with cohort one administering 25 milligrams of its novel ketamine formulation. It received approval from the ethics committee and the principal investigator, along with positive feedback from the site monitor. Moving ahead, the team anticipates completing cohort two (50 milligrams) and cohort three (100 milligrams) by early 2024, marking the culmination of the Phase 1 clinical trials. This progress signifies a significant step toward validating the safety and efficacy of its novel NeuroDirect ketamine formulation.

Psycheceutical’s mission to enhance the safety and affordability of psychedelic medicines holds the promise of expanding access to life-saving treatments for individuals grappling with mental health disorders and central nervous system diseases. With its innovative delivery technologies, the company is reshaping the psychedelic therapeutics landscape and contributing to a future where transformative treatments are more accessible to those in need.