FDA rejects MDMA for use, calls for more research

On Friday, drugmaker Lykos Therapeutics received word from the Food and Drug Administration that the agency has decided not to approve MDMA-assisted therapy for PTSD at this time. Instead, the agency asked the drugmaker to further study the safety and efficacy of the treatment.

The heavily anticipated announcement came in the form of a “complete response letter” from the FDA to Lykos, according to a company press release.

It represents a significant setback for the company and the broader movement to bring psychedelics into the mainstream of mental health care.

“It’s a huge blow to the field,” says Dr. Boris Heifets, an anesth…

Those hoping to see MDMA make it to market argue that concerns about the quality of the research were overblown and, in some cases, focused on issues with the study design that weren’t unique to MDMA.

The trials “undoubtedly had problems,” says Stanford’s Heifets, but the FDA could have dealt with those concerns by approving the treatment with strict restrictions around how it’s administered and a requirement to do a post-market study.

He worries the decision to deny approval will stifle innovation and funding into other novel treatments, including MDMA-like drugs that are being developed.

“The FDA has gone against advisory committee advice [in the past]. It has approved drugs with abuse potential,” says Heifets. “None of this is that radical, so I think they could have done something else here.”

On the other hand, Marks says that approval would have required the FDA to “pile on” so many restrictions because of concerns about the Lykos’ application that ultimately it would have been “impractical” for the treatment to reach many people.

He also wonders whether the all-out publicity blitz by Lykos and its allies was, in the end, “counterproductive” because it put the FDA in an awkward position by making the decision so politicized.

“This is not the end of the road for Lykos,” he says, “It will cost them financially, but it doesn’t mean they can’t ultimately succeed.”

The push to establish MDMA-assisted therapy as a legitimate treatment for PTSD stretches back two decades.

Researchers affiliated with the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, pioneered the early studies and developed the therapy protocol embedded in the treatment. That work ultimately set the stage for the drugmaker, which was incubated by MAPS, to press forward with larger human trials and seek approval from federal regulators.

Lykos has raised more th…

Follow-up research from the company showed participants were still benefiting from the treatment at least half a year after their last dosing session.

“Although disappointing, this move by the FDA highlights the importance of conducting rigorous research into the safety and efficacy of MDMA-assisted therapy,” says Alan Davis, director of the Center for Psychedelic Drug Research and Education at the Ohio State University, “Despite this setback, I am hopeful that there will be a better outcome down the road after more research is completed in the coming years.”

Debate over the merits of the Lykos’ application has become increasingly divisive, with allegations that misconduct and bias in the clinical trials compromised the findings and undermined its safety. The drugmaker and many of the therapists involved in the research have steadfastly denied those claims.

It’s unclear to what extent any of this factored into the FDA’s deliberation on the therapy.

In response to Friday’s decision, Emerson reiterated the company’s plan to push the research forward, saying they’d “work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients.”

Given what’s required to conduct another trial, Heifets believes psilocybin is now poised to gain approval ahead of MDMA.

## Conclusion
The FDA’s decision not to approve MDMA-assisted therapy for PTSD at this time has dealt a blow to the field of mental health care and psychedelics research. While supporters of the treatment had high hopes for its approval, concerns about the quality of the research and the need for further study have led to this setback. The future of MDMA as a therapeutic option for PTSD remains uncertain, but ongoing research and advocacy efforts may pave the way for its eventual approval.

## FAQs

### Is MDMA-assisted therapy effective for treating PTSD?
While promising results have been seen in clinical trials, the FDA’s decision not to approve the treatment indicates that further research is needed to confirm its safety and efficacy.

### What is the future of psychedelics research in light of this decision?
The FDA’s stance on MDMA-assisted therapy may influence the development and approval process of other psychedelic treatments in the pipeline, such as psilocybin and LSD. Continued research and advocacy will be crucial in shaping the future of psychedelics in mental health care.

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