For the first time, the U.S. Food and Drug Administration (FDA) has issued draft guidance for psychedelic clinical trials.
The new draft guidance highlights considerations for researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions, including psychiatric or substance use disorders.
The publication of the draft is a response to the exponential increase in research across the US and the globe, looking at the compounds for a number of different mental health conditions such as depression, anxiety and PTSD, as well as for conditions such as stroke and eating disorders.
However, the FDA highlights that designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of challenges that require careful consideration.
Tiffany Farchione, M.D., Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, stated: “Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.
“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programmes and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
Study design and other considerations
The FDA notes that the draft refers to “classic psychedelics” – psychedelics that are understood to be 5-HT2 agonists, such as LSD or psilocybin – and “entactogens” or “empathogens” such MDMA.
Considerations contained in the draft include trial conduct, data collection, subject safety and new drug application requirements.
For example, the FDA has noted that researchers must put sufficient safety measures in place for preventing misuse throughout clinical development.
Other considerations include requiring the pharmacokinetics/pharmacodynamics of psychedelic drugs to be adequately characterized both in vitro and in vivo – such as evaluating the effect of high-fat meals on the pharmacokinetics of an oral psychedelic drug early in development to inform clinical study design and potential, or excluding subjects with pre-existing valvulopathy or pulmonary hypertension from multiple-dose studies of 5-HT2B agonists – as long-term exposure may induce cardiac valve stiffening.
The FDA has also highlighted that, for psychedelics that are currently Schedule I controlled substances, “the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration regulatory requirements.”
The industry and public are invited by the FDA to provide comments on the draft guidance within 60 days of its publication to ensure they are considered.
Psychedelic therapy programmes launch to address heartbreak, burnout and more
Mindbloom has launched its new Mastermind Series of psychedelic programmes for overcoming heartbreak, burnout and other unique mental health challenges.
Led by and developed with leading experts in the field, each programme combines specialised teachings with ketamine therapy.
All programmes will include six ketamine therapy sessions focusing on a specific mental health issue, expert-led audio, video, and written content for preparation, treatment, and integration, practical tools such as meditation, one-on-one coaching and group integration sessions.
The first programme in the Series is ‘Recovering from Rejection and Failure’, led by Dr Guy Winch who is a leading authority on emotional health, and a best-selling author and TED speaker whose talks have received over 30 million views.
Winch’s programme focuses on healing and preventing emotional injuries that people suffer in their personal, professional and romantic lives.
Mindbloom CEO and Founder Dylan Beynon stated: “More than 100 studies and 20 plus years of clinical use show that ketamine therapy may be the most transformational mental health treatment available today.
“In the face of epidemics of mental illness, addiction, and loneliness, we’re thrilled to offer our clients access to top experts across a range of issues – and to pair their expertise with our best-in-class ketamine therapy honed over hundreds of thousands of treatment sessions.”
“Emotional wounds like rejection and failure can be even more devastating than physical wounds, yet we don’t give them the same time and attention,” added Dr Winch.
“I’m thrilled to combine my techniques for emotional first aid with ketamine therapy, which has been shown to increase neuroplasticity and help build emotional resilience.”
“Americans are struggling with heartbreak, burnout, and other challenges every day, and they’re looking for new tools to address them,” said Mindbloom’s Medical Director Dr Leonardo Vando.
“I’m grateful to these experts for providing Mindbloom’s clients with the unique practices and insights they’ve cultivated during their distinguished careers, to help them overcome the biggest obstacles in their lives.”
Mychedelica launches to revolutionise psychedelic medicine
A new company specialising in psychedelic medicine – mychedelica – is offering a comprehensive suite of services to support the advancement of this transformative field.
With a team of experienced medical writers and research support specialists, mychedelica is committed to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in the psychedelic medicine space.
Psychedelic medicine is rapidly gaining recognition for its potential to treat a wide range of mental health conditions, including depression, anxiety, addiction, and post-traumatic stress disorder (PTSD). However, the field is still in its early stages of development, and there is a critical need for high-quality medical writing and research support services to facilitate its progress.
CEO of mychedelica, Bilal Bham, commented: “We are thrilled to launch mychedelica and contribute to the advancement of psychedelic medicine.
“Our team of experienced professionals is dedicated to providing the highest quality services to researchers, clinicians, and pharmaceutical companies working in this groundbreaking field.”
mychedelica provides a comprehensive range of services, including:
Medical writing: Experienced medical writers will craft clinical trial protocols, regulatory submissions, and peer-reviewed publications, ensuring that research findings are communicated clearly and effectively.
Funding research support: Experts in grant writing and fundraising strategies will assist researchers in securing funding for their psychedelic medicine studies.
Regulatory consulting: mychedelica’s team of regulatory experts will navigate the complex regulatory landscape surrounding psychedelic medicine, ensuring that clinical trials and products comply with all applicable laws and regulations.
With its commitment to quality and innovation, mychedelica is poised to play a pivotal role in shaping the future of psychedelic medicine. The company’s services will empower researchers to conduct rigorous clinical trials, clinicians to provide effective treatments, and pharmaceutical companies to develop safe and effective psychedelic medicines.
Short Wave Pharma: innovating eating disorder care with psychedelics
Psychedelic Health speaks to Short Wave Pharma CEO Rivki Stern about the company’s plans to innovate eating disorder care through psychedelics and its recent acquisition by Psych Capital.
Short Wave Pharma was recently acquired by global investment firm Psych Capital. The companies are on a mission to transform mental health care, focusing on innovative approaches and treatments, including psychedelics, which are increasingly gaining acceptability as clinical research results accumulate.
Short Wave Pharma’s clinical programmes are particularly focused on Anorexia nervosa – a complex mental health condition with one of the highest fatality rates. Despite the condition being associated with high rates of suicide, it is a hugely underserved area of mental health, with no FDA-approved pharmacological drug, and a high rate of chronicity.
The company has developed a novel delivery method and drug combination specifically designed to address the requirements of this vulnerable population. Short Wave focuses on methods of delivery that will be effective for Anorexia, which is a metabolic disease as well as a mental health condition. Its unique buccal film delivery method is intended to affect the brain while bypassing the liver and gut degradation through mucoadhesive absorption.
“Our goal is to alleviate, solve, and treat mental health conditions. It’s a dire need in our global society, and it’s constantly on the rise,” commented Stern. “Eating disorders are a very good example of that and we have seen a very alarming growth since COVID.
“What drew our attention to psychedelics is that they have the potential to address very complex mental health diseases and have been designated by FDA as breakthrough medicine for life-threatening conditions.
“Because there are no current solutions, we must harness very innovative approaches and potential solutions. That’s why we started working with psychedelics which may be difficult because they are not regulated, but we don’t shy away from challenges.”
The company’s drug is based on psilocybin and another API which together utilise an expanded mechanism of action and a therapeutic effect superior to psilocybin alone, impacting more than one group of receptors in the brain.
The delivery method is sensitive to the patients’ needs – who may not want to swallow or be injected – and is known for its high bioavailability.
“By mucosal absorption, we are speeding the onset of the medicine and amplifying the impact which will help tackle the patients’ metabolic challenges and improve acceptance,” says Stern.
The drug product and delivery method are currently in preparation for Phase 1 clinical studies, and in its current preclinical studies, the company is validating its delivery and expanded mechanisms of action. So far, initial safety results are positive, with a further, more in-depth toxicity study taking place.
Psych Capital – which is a public investment and awareness platform for mental health, and has a portfolio of innovative companies – has supported Short Wave Pharma’s IP-driven approach to eating disorder care through its recent acquisition of the company.
Short Wave and Psych Capital say they are aligned in their missions to innovate mental healthcare and deliver transformative care in areas of high unmet need.
Stern commented: “We all share a passion for innovation and together have decades of experience in evaluating investments as well as scaling up R&D projects and start-ups in life sciences.
“We have a shared commitment to alleviate the suffering from mental health. Every one of us has experienced the frustration and challenges of dealing with mental health issues.
“Together, we’re going to put this commitment into action, by bringing forth innovative solutions and developments and getting them through the first stages of development, from discovery through to early phases of clinical study.
“With psychedelics components, this is extra challenging because of their status as scheduled drugs within a still evolving regulatory framework, which adds uncertainty to the drug development process.
“Short Wave Pharma has operational expertise in early-stage drug development which will bring extra value to the group’s projects as they develop through our funnel and grow into promising candidates for mental healthcare.
“We want to identify the gems, guide them through clinical development, and create the right network to attract the right partners for further development and commercialisation.”
Short Wave Pharma is planning to enter its treatment into clinical studies in 2024.
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