As many will have seen, the FDA in the United States announced on Friday that it has rejected the MAPS registration application for MDMA when used as part of therapy. After the second Phase 3 results were announced by MAPS last year it looked like MAPS would have a straight-forward route to registration. However, over time a lobbying campaign against registration gained momentum, and a recent campaign in support (which included Veteran associations and Members of Congress) was too slow to have any impact.
The rejection letter to the MAPS sponsoring company (Lykos) from the FDA has not yet been made public but some of the details are starting to come out (eg. a requirement from the FDA that Lykos sponsor a new Phase 3 trial to further test safety and efficacy). That will be challenging for Lykos to fund and will put registration back by a number of years. Lykos has asked the FDA to reconsider its position, but any change (at least from this distance) seems unlikely.
A good summary of the FDA’s decision can be found here: https://psychedelicalpha.com/news/breaking-fda-rejects-lykos-therapeutics-mdma-assisted-therapy-for-ptsd
The arguments used by the FDA Advisory Panel (which appear to have been adopted by the FDA) look superficial and/or manageable. For example, the challenges with blinding that were raised by the Advisory Panel have been obvious for a long time. Using the same argument, this should also have been a problem with the registration of the ketamine nasal spray Spravato (esketamine) but in that case the sponsor – Johnson and Johnson – was a conventional pharmaceutical company better known to the FDA. Another argument raised by the Advisory Panel was the vulnerability of patients to abuse when in an altered state, a risk that we believe can be controlled by having two therapists in the room with the patient at all times, the sessions being visually recorded and the recording being available for review. It really does seem a strange argument because the same argument could be applied to patients being given morphine for pain relief or patients being given a general anaesthetic.
We have provided a full analysis of the arguments raised by the Advisory Panel in a paper co-authored by Professor David Nutt (Imperial College London), Tadeusz Hawrot (PAREA – Europe), Peter Hunt (Mind Medicine Australia) and Dr Anne Schlag: https://www.drugscience.org.uk/allaying-the-fears-mdma
We think that this is just a setback and that MDMA will be registered as a medicine in the United States by the FDA in time and that the public campaign for registration in the United States will just keep getting stronger. The suicide rate and suffering amongst veterans, first responders and others, which hasn’t been helped by the failure of current treatments, will continue to highlight why this treatment needs to be available (with appropriate controls in place). Unfortunately, more people in the United States who are suffering from mental illness will continue to take their own lives or seek illegal access to MDMA-assisted therapy (with no regulatory supervision) in the meantime.
What this outcome does show is the wisdom of the TGA’s decision to reschedule MDMA and psilocybin when used as part of therapy for PTSD and treatment resistant depression by combining this with the controls in place under the Authorised Prescriber scheme. We just have to be careful that the regulatory controls don’t unfairly inhibit access for patients in Australia who satisfy the criteria, where both the prescribing psychiatrist and the patient – properly informed – agree that it’s an appropriate and much needed treatment for the patient. We also need to carefully review any claims that are made against the use of these therapies (including through conflicts of interest and lack of proper analysis).
