MAPS Wins Appeal to Study MDMA in Healthy Volunteer Therapists in Phase 1 Trial
Last week, MAPS won an appeal over the 20 month clinical hold on plans for a Phase 1 MDMA trial*.
Key takeaways and commentary:
"Phase 1 clinical trials of MDMA-assisted therapy for clinicians will measure development of self-compassion, professional quality of life, and professional burnout"
This is timely, given MAPS' recent Phase 3 trials on MDMA for PTSD. Whilst it is often assumed that drug development follows a strict linear progression, new data from Phase 1 trials can influence Phase 2 and 3 trials already underway. Therefore, this Phase 1 trial can add data to the reproduction of the Phase 3 trial, plus to other current Phase 2 trials (for example, for eating disorders and social anxiety)
"The study, one of few legal means by which therapists can experience the treatment they provide in MDMA-assisted therapy for PTSD, was placed on clinical hold by the FDA for 20 months"
The hold was enforced due to concerns about (i) the scientific merit of the trial, (ii) risk-to-benefit ratio for healthy participants, and (iii) the investigator qualifications. However, MAPS argued this study does not differ in risk or investigator qualifications from a prior, similarly designed Phase 1 study approved in 2009. And, as stated above, these Phase 1 trials hold scientific merit in supporting other ongoing trials. It is also argued that the first hand experience therapists will gain may help in their training and later use of this treatment with patients. Therefore, the rationale for a clinical hold is not supported.
FDA’s Office of Neuroscience granted the appeal on the grounds of scientific merit, the absence of unreasonable risk to participants, and appropriate investigator qualifications
This shows that challenging FDA rulings can prove successful, when done strategically and using data-driven approaches. Rick Doblin commented: “this is MAPS at its best, negotiating with the FDA in an evidence-based manner with existing and new data that we analyzed specifically for our response."
*a phase 1 trial is one in which researchers test a new treatment in around 20-80 healthy volunteers. The purpose is to evaluate the safety, before it can progress to trials which test its efficacy.
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