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Overcoming Hurdles in Psychedelic Treatment Development: Navigating the Regulatory Maze

Hippie Counter-Culture or Wonder Drugs? In recent years, the resurgence of interest in psychedelic substances as potential therapeutic tools has captured both scientific curiosity and public imagination. However, the journey towards integrating these substances into mainstream medicine is fraught with challenges. From regulatory hurdles, laws, and regulations to societal stigmas, the path to developing psychedelic treatments is riddled with complexities.

This article from KreaMedica explores some of the common hurdles to developing psychedelic treatments as well as the research being done to bring these treatments into mainstream use and widespread acceptance.

A Resurgence in Psychedelics?

Some might think there’s a resurgence in psychedelic study and research, but underlying work has been occurring for decades. The most notable example of psychedelic development is in the Johns Hopkins Center for Psychedelic and Consciousness Research, which first received approval to conduct research in 2000. Their 2006 landmark publication sparked a renaissance and knocked open the door to data-backed, peer-reviewed psychedelic research.

But Johns Hopkins isn’t the sole force catalyzing this research:

Increasing Momentum in Psychedelic Research and Development

One cause for the increased momentum in psychedelic research can be linked to the efficacy of existing pharmaceuticals, specifically in the arena of mental health. Regular or standard medications work; they treat a specific symptom but do not address the overall well-being of the patient.

For example, many patients experiencing depression and anxiety experience treatment resistance or sporadic improvement. The drugs we currently have at our disposal aren’t consistently effective and often require complementary medicine to achieve results.

New treatments and approaches are desperately needed to combat these illnesses and the issues that stem from them. Researchers are looking more deeply into psychedelics as the answer. Data suggests that psychedelic-assisted treatments may be effective for some of our most prevalent, debilitating, and fatal conditions.

Studying healthy volunteers also advances our understanding of the enduring positive effects of psilocybin and provides unique insight into neurophysiological mechanisms of action, with implications for understanding consciousness and optimizing therapeutic and non-therapeutic enduring positive effects.

Overcoming a Strictly Biology-Based Approach: Psychedelics and Consciousness

Today, we must consider the whole person in treatment, including the workings of the mind. Psychedelics demonstrate an increase in the neuroplasticity of the brain, creating new connections, ideas, and an expansion of consciousness that might be the foundation for improvements in mental health care.

Consider loneliness: people feel lonelier than ever before. And this ache is the root of many mental health issues and crises that plague our societies, including anxiety and depression. Though these may be normal responses to abnormal circumstances, how do we expect those suffering to cope? Historically, we have turned to psychological therapy, drugs and sedation, but psychedelics provide an alternative route, namely, expanding minds, increasing connections in the brain, and possibly empowering individuals to re-think old issues/problems, change, and adapt more efficiently and effectively.

Our understanding of the neurology of the mind and being is only at the early stages, primarily because it blends physical, biological structures in our brain with the undefined nebulous that we call consciousness. We must approach health not just from a biological and chemical perspective but also from the perspective of awareness and consciousness in our mental health as well as the impact respective communities and society has on our entire being.

Schedule One Drugs: A Lasting Stigma

Supporters of the therapeutic application of psychedelic substances argue that this promising field for treatment was prematurely discarded during the 1960s, primarily due to Richard Nixon’s ‘War on Drugs.’ For various cultural and political motivations simmering at this time, psychedelics were categorized as Schedule I drugs. And despite decades of research and development, the categorization –– and associated stigmas –– remain.

The Schedule I classification has created various obstacles to therapeutic research and implementation. In addition to a societal leeriness regarding psychedelics, of significant impact was the heightened regulation of pharmaceutical research following the Thalidomide crisis in 1963. Furthermore, clinical research faced obstacles after 1965 when Sandoz discontinued the provision of psychedelic substances for research purposes, and their non-medical usage was prohibited in 1970.

Regulatory Hurdles

As drug companies explore the potential of psychedelic treatments, overcoming regulatory hurdles remains the most significant roadblock to development. Finding the right consulting partner empowers you to take control of your project and create streamlined, strategic pathways to development. It’s here that KreaMedica supports, empowers, and propels our partners to clinical success.

Our seasoned consultants have decades of experience guiding our clients through regulatory compliance. We provide proven, trusted consulting to accomplish the following:

  • Help you establish a relationship with the relevant organizations and regulatory agency
  • Select and support the right CRO for your project
  • Create a model wherein you prove primary pharmacology, proof of concept, and mechanism of action
  • Build a package for the appropriate FDA division, including relevant literature that justifies and references your trials
  • Meet with the agency and submit your proposal
  • Receive feedback and take action steps
  • Address chemistry, manufacturing and control issues

Additionally, we can be your US agent and regulatory lead.

You will encounter many regulatory hurdles. The team at KreaMedica helps you overcome them by providing strategic guidance and movement throughout application, maintenance, and continued communication with the governing bodies.

The Future of Psychedelics

We’re in an exciting time for drug development and the exploration of psychedelic treatments. Decades of research are finally pushing many to consider, for the first time, what role psychedelics play in healthcare and how adopting these treatments might have a profound effect on the future of our global community.

At KreaMedica, we know many moving pieces must operate harmoniously to move any drug development project forward. This is especially true of any developments in psychedelic treatment. Our team has the expertise and networking capabilities to support your project at every stage of development. Reach out today to learn how we can help you strategically overcome hurdles to developing psychedelic treatments and see your project to completion.

Author: Aurora Sosa
During her 30+ years in industry, Aurora worked for over 20 years in international regulatory affairs, both within biotech & pharma companies as well as in a regulatory consultancy role. She has in-depth experience within many therapeutic areas such as neurology, (including neuroimmunology and neuroinflammatory disease), gastrointestinal disease, anti-infectives, infectious disease, cardiovascular, anti-inflammatory disease, dermatological disease, respiratory, ophthalmology, rare disease, unmet medical need  and rare pediatric diseases, as well as working with plasma derived drug products for rare blood disorders such as hemophilia, factor IX and for alpha 1 antitrypsin deficiency and weakened immunity. She is a proven team leader having worked  successfully in cross functional team environments.