FDA Denies the Lykos (formerly MAPS) Therapeutics Application for MDMA-Assisted Therapy
Image source: lucid.news
From Lykos (formerly MAPS PBC):
"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Emerson - CEO of Lykos.
Larger context:
In the 1970-80s, over 4,000 psychotherapists were successfully using MDMA to support clients with a range of mental health challenges. MDMA showed the potential as a catalyst to support psychotherapy by helping diminish the brain's fear response, allowing people to access and process painful memories without being overwhelmed. This work was being done 'underground' and is documented in the Secret Chief Revealed.
Then MDMA became a rave drug. Reporting about MDMA deaths (a real risk from dehydration or combining with other psychotropics) was massively overreported. [MDMA rave history --- scroll to graphic comparing reporting]
In 1985, the U.S. Drug Enforcement Administration ("DEA") said drugs are bad m'kay and made MDMA a Schedule I drug under the Controlled Substances Act, preventing it from being used for recreational or medical use. Schedule 1 means no recognized medical use and high risk of abuse potential. The designation was a political decision, not scientific. [Read history of MDMA criminalization]
PTSD affects approximately 13 million Americans each year with women and disadvantaged or marginalized groups more likely to be affected. Military personnel also have a greater prevalence of PTSD than the general population. Phase 2 studies indicated significant symptomatic reduction when MDMA was combined with therapy (MDMA-AT = MDMA Assisted Therapy). [Read Nature paper]
In 2017, MDMA-AT was granted the Breakthrough Therapy designation for the treatment of PTSD by the FDA in 2017, Lykos says it has worked “in collaboration” with the agency to design the trials now being evaluated.
Bipartisan support for the use of MDMA exists - from Dan Crenshaw (R-TX) and Alexandria Ocasio-Cortez (D-NY). [Read article]
Earlier in 2024, an FDA Advisory Committee (AdComm) published disapproval of the MAPS research protocol. The main critiques indicated the studies were safety risks, study design, and research methods. Specifics mentioned: misconduct from therapists, lack of functional unblinding (the therapists and patients could tell they were on MDMA), ~30% of patients had previous MDMA experience, and follow-up (6-months) was too short. [See Lykos statement]
Other companies are pursuing FDA trials for MDMA and other psychedelics. While this FDA decision is a blow to Lykos, the number of active trials reinforces the evidence in the efficacy of these compounds to change lives. [See psychedelics.alpha]
If Lykos is required to submit an additional phase 3 trial, it would require at least $100M and two years to complete and resubmit. Given their recent fundraising challenges and this setback, it may not be possible for them to fundraise this amount through philanthropic or capital raises.
While Lykos (formerly MAPS) indicated for years they would not patent MDMA, last year they decided to shift their strategy and offer a formulation they could patent - called midomafetamine capsules. [See lykos therapeutics]
Speculation has been voiced that if the FDA had allowed a study with significant flaws through their approval process, it could have created a precedent that would allow 'big pharma' to push sloppy science through their system. In a way, this is the FDA system maintaining its integrity. (Recall, the FDA is still reeling from approving opioids and the impact those have had across the country).
