37 GHP Q4 2023 n light of promising research on the efficacy of psychedelics, there is a surge in activity and investment in bioscience-driven treatments for mental health. As it stands, the industry’s future appears exceptionally promising, with numerous innovations and innovators setting the pace and continuously propelling the momentum forward. It perhaps goes without saying that Psycheceutical is one of these innovators, built on a robust foundation of research, expertise, and cutting-edge technology to establish best practices and benchmarks for others to follow. For Harman, the use of psychedelics for mental health treatment is the future of the sector. “We believe that psychedelic medicine will soon become the preferred treatment option for those who are suffering from mental health disorders such as depression, anxiety, substance and alcohol abuse, and PTSD. Our mission at Psycheceutical is to develop and commercialize cutting-edge delivery technologies that provide safe and effective psychedelic medicines for mental health treatments. We are combining the therapeutic aspects of psychedelics with the controlled dosing of pharmaceuticals – thus creating ‘psycheceuticals’ to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases,” said Harman. “Our next-generation patented technologies, via systemic and nonsystemic routes of administration, are designed to bypass the blood-brain barrier (BBB) to allow psychedelics to be administered without abuse potential, hallucinogenic side effects, and toxicity to the liver and kidneys,” Harman added. Fundamentally, Psycheceutical is a driving force in this space, creating a platform of drug development and delivery technology that helps ‘raise the tide’ for others working to develop their own treatments. The company’s position remains one of leadership, with its technologies designed on a twopillar approach of efficacy and safety. One of the notable challenges of this industry lies in upholding the stringent regulatory standards for safety in order to obtain regulatory approval. Furthermore, achieving enduring success in psychedelic treatments demands constant diligence and innovation, especially when striving to match the efficacy of common pharmaceutical treatments and ensuring comparable levels of accessibility. “There is also a strong interest in removing the hallucinogenic effects and abuse potential of psychedelics in order to speed up the approval process and appeal to a wider market,” Harman notes. “Many companies in the psychedelic sector are engaged in drug development initiatives, with a majority attempting to alter the molecular composition of psychedelic substances to eliminate their psychedelic properties. Their goal is to create and secure patents for these unique psychedelic compounds. Regrettably, this approach adheres to the conventional 505(b)(1) drug development route, necessitating comprehensive preclinical studies and FDA approvals, resulting in increased costs and extensive timelines. This process differs from Psycheceutical, where we are instead focused on the 505(b)(2) pathway in developing next-generation brain-drug technologies to safely deliver established psychedelic molecules with decades of supporting clinical data.” Psycheceutical, Inc. is a bioscience company that is spearheading much needed change in the delivery and development of psychedelic-assisted treatment for mental health disorders. With their exciting drug delivery technologies and mission to transform the mental health space, GHP has recognized Psycheceutical as this year’s Ones to Watch for Innovative Mental Health Treatments. We spoke with CEO Chad Harman to find out more. Accelerators of Needed Change in Mental Health Ultimately, the future of Psycheceutical is one of further development and expansion into brain-delivery technology. While the current focus will remain on psychedelic treatment, the company plans to expand their delivery technologies to treat neurodegenerative disorders like Parkinson’s, Alzheimer’s disease, and Traumatic Brain Injuries (TBI). In the near future, Psycheceutical believes it will be working with the world’s largest pharmaceutical companies to provide technologies for the accurate and safe dosing of psychedelic medicines for a number of mental health conditions. NeuroDirectTM: a topical ketamine treatment for PTSD. The first drug in Psycheceutical’s development pipeline is their NeuroDirectTM ketamine topical for the treatment of PTSD. The market size for PTSD treatment is immense at over $16 billion per year, with no signs of decreasing in the foreseeable future. This is because there are few effective treatments for PTSD, opening the way for viable alternatives such as psychedelic medicines. As it stands, Psycheceutical’s clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder. Here, Harman discusses the company’s work in bringing NeuroDirect to market: “We’ve selected ketamine because it is currently the only legal psychedelic compound on the market. Our novel NeuroDirect ketamine topical cream to treat PTSD has already shown positive results in an observational clinical setting. A recently published study in Drug Development & Delivery describes the potential of our 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. We also recently announced the successful dosing of our patented NeuroDirect topical ketamine formulation in a Phase I clinical trial. Key results from the study confirmed the topical administration of NeuroDirect ketamine to be safe and well-tolerated.” Company Name: Psycheceutical, Inc. Contact Name: Michael Hlavsa, CFO Address: 515 E. Las Olas Blvd. Suite 120, Fort Lauderdale, FL 33301 Socials: https://www.facebook.com/psycheceutical/ https://www.twitter.com/psycheceutical/ https://www.instagram.com/psycheceutical/ https://www.linkedin.com/company/psycheceutical/ https://www.youtube.com/@psycheceutical Web Address: https://psycheceutical.com/ Contact Email [email protected] I
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