Written by Psychedelic Alpha Medical Advisor Michael Haichin, PharmD, and Josh Hardman as part of the Pα+ Library.
As we look ahead to potential approvals of psychedelic therapies, we’re paying increasing attention to what its delivery might look like. Needless to say, there are many ‘unknowns’. To be sure, some of these will be ‘unknown unknowns’—to use a Rumsfeldian quip—but many can be anticipated.
One such matter that’s sure to significantly contour what the eventual delivery of FDA-approved psychedelic therapies ‘looks like’ is REMS: Risk Evaluation and Mitigation Strategies. These are sometimes mandated by bodies like the FDA where it believes certain additional safeguards are necessary to achieve an acceptable risk-benefit balance: i.e., to see that benefits outweigh risks.
We are confident that a REMS program will be required for psychedelic-assisted therapies. This is due to several factors that aren’t discussed at length here but include potential safety concerns (demonstrated even in tightly controlled clinical trials in closely-curated patient populations), a history of ‘misuse’, and their finicky mode of delivery as a drug-assisted therapy.
REMS often include less onerous elements, such as medication guides or patient packet inserts (sheets of paper given to patients containing pertinent information about a drug) and communication plans (materials that support the implementation of REMS, directed to healthcare providers).
However, they can also include Elements to Assure Safe Use (ETASU). These are mandated measures that can extend to prescribers, dispensers, those administering the drug, monitoring the patient, and so on. This is the aspect of a psychedelic REMS that could be most pivotal and will be the most critical portion of REMS negotiations between sponsors and the FDA.
Here, we very sketch out what a psychedelic REMS might look like, which should go some way to highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.
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Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.
The Pα+ Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.
