Over the Hurdles: Taking Psychedelics from Schedule I to Pharmacy
Richard Sidwell, Ph.D., Senior Vice President and Chief Scientific Officer
Mental health is a complex subject that’s getting a fresh look from many angles. One particularly intriguing frontier is the potential of DEA Schedule I psychedelics for therapeutic use. Here at Societal CDMO, we’ve been navigating the ins and outs of pharmaceutical development for over 30 years. And while we’ve seen some groundbreaking shifts in the field, the emergence of psychedelics in clinical research is something truly exciting.
The Potential of Psychedelics in Modern Medicine
What if someone told you that some Schedule I substances — you know, the ones typically off-limits in medical research — might be packed with untapped therapeutic potential? Recent studies are starting to paint an interesting picture. They suggest that psychedelics such as psilocybin, MDMA, and LSD could play a game-changing role in managing conditions such as depression, PTSD, and even addiction. With societal perceptions of these substances beginning to shift, we’re standing on the edge of a new era of research and discovery.
Recent Clinical Activity and Trends
The world of clinical research is active around psychedelics. From studies examining their safety to trials testing their efficacy, the pace of discovery is quickening. This wave of research is giving us invaluable insights into the potential of these substances, which have traditionally been avoided due to stigma and regulatory restrictions.
Here are just a few recent publications reviewing the therapeutic use of psychedelics:
Nutt, D., Erritzoe, D., & Carhart-Harris, R. (2020). Psychedelic psychiatry’s brave new world. Cell, 181(1), 24-28.
Smith, K.W., Sicignano, D.J., Hernandez, A.V. and White, C.M. (2022), MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder: A systematic review with meta-analysis. The Journal of Clinical Pharmacology, 62: 463-471.
Dawood Hristova, J. J., & Pérez-Jover, V. (2023). Psychotherapy with psilocybin for depression: Systematic review. Behavioral Sciences, 13(4), 297.
Recent Investment in Psychedelic Research
Just as we’re seeing a burst of activity in research of psychedelics, there’s a parallel upswing in investment. The promise held by these substances hasn’t gone unnoticed by investors, leading to a surge of funds flowing into the field. The result? More research, more start-ups, and a growing interest from established pharmaceutical companies keen to explore the potential of psychedelics. The US government is also interested in the space, as shown by the recent notice of funding opportunity (NOFO) issued by NIH/NIDA “to encourage clinical research that will advance understanding of how substance use disorder (SUD) relevant cognitive, emotional, and social processes are modulated by Psychedelics” (2023, NIH).
Here are a few more recent publications about investment funding for psychedelic pharmaceutical development:
- Cunningham, Meg. (February 23, 2023) Wall Street gets behind next wave of mental health treatment: Psychedelics. Investopedia.
- Lee, Yeji Jesse (Mar 9, 2023) What to know about the booming psychedelics industry, where companies are racing to turn magic mushrooms and MDMA into approved medicines. Business Insider
- NIH, (May 16, 2023), Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required), NIH/NIDA
Hurdles in the Development of DEA Schedule I Psychedelics
Of course, it’s not all smooth sailing. Developing Schedule I psychedelics for legal pharmaceutical use comes with a unique set of challenges. The regulations around obtaining DEA approval and meeting FDA requirements can be tricky to navigate, not to mention the issues related to importation and quotas that can affect substance availability. Then there’s the all-important focus on safety, which requires rigorous attention to handling, engineering controls, PPE, and security measures. It’s clear that this path while promising, isn’t without hurdles.
How Societal CDMO Can Help
Here’s where our experience comes in handy. We’ve held DEA registrations for manufacturing Schedule II substance finished products and successfully navigated the complexities of development and commercial manufacturing for about two decades. Not only have we maintained good standing through numerous FDA and DEA audits, but we’ve also developed a deep understanding of the regulatory landscape and safe handling of these compounds. We’re confident that this track record and level of related expertise will allow us to obtain a license for DEA Schedule I substances as we begin to work with clients in this area of clinical research and drug development.
Our journey in the pharmaceutical world has taken us through the realms of finished product development, cGMP clinical supply manufacturing and packaging, and commercial manufacturing and packaging. Each step has equipped us with valuable insights and capabilities that we’re excited to apply to the emerging field of psychedelic research.
At Societal CDMO, we’re interested in helping our clients develop and manufacture their new therapies in this field so they can start helping patients as soon as possible. If your organization is seeking a seasoned, knowledgeable partner to navigate the development and manufacturing of DEA Schedule I psychedelics, we invite you to reach out. Let’s explore the potential of these substances together and contribute to the next evolution in mental health treatment. Contact us today to start the conversation.
To learn more about our experience within this area, please visit our controlled substances page.