The FDA is currently in the final stages of the MDMA-Assisted Therapy approval process, with the decision expected in August 2024.
The next stage in the approval process is the meeting of the FDA Advisory Committee on June 4 to review Lykos Therapeutics’ application. The committee is composed of independent experts, and its objective is to advise the FDA on whether this novel therapy has therapeutic merits and whether it is safe.
Interestingly, as this potentially historic FDA decision approaches, Lycos and MAPS are getting some pushback. Among the most notable recent efforts is the March report from the Institute for Clinical and Economic Review (ICER) that claims that there is not sufficient clinical evidence for the effectiveness of MDMA-Assisted Therapy for PTSD.
In response to ICER’s report, one hundred and nine therapists and investigators from the MAPS FDA trials wrote a letter criticizing the report. Lycos also issued a statement, and many others commented. None of this changed the ICER’s position.
I will not get into details here as I simply have no time or desire to get bogged down in this, in the same way it felt pointless to engage with the Power Trip Podcast, which brought to public attention some instances of gross ethical violations related to early MAPS trials, but then in an utterly sensational and distasteful manner attempted to discredit the whole field. Notably, the ICER’s report is based on the accounts of a select group of individuals associated with Power Trip.
I see this controversy as another example of a political battle we can see everywhere these days, where facts matter less than rhetoric, and where one repeats the same statements because the words matter more than what the words mean. The sad and scary part of this is that this strategy often works, so let us see what June 4 is going to bring us.
For a detailed and balanced analysis of all these developments, I refer you to an excellent independent industry analyst Josh Hardman at Psychedelic Alpha https://psychedelicalpha.com/
* Note that MDMA is illegal and MDMA-Assisted Therapy is not approved for any use at this time. We do not encourage or condone the use of MDMA in any context.
