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After much anticipation, the US Food and Drug Administration (FDA) has decided not to approve the use of MDMA – in addition to therapy – for the treatment of PTSD, just for now.

This comes as bad news for drugmaker Lykos Therapeutics, as well as the growing movement of experts who wish to bring psychedelics into the mainstream of mental health care.

According to a company press release, the FDA denied Lykos request for approval, instead asking the drugmaker ‘to further study the safety and efficacy of the treatment’. Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision.

“It’s a huge blow to the field,” says Dr. Boris Heifets, an anesthesiologist at Stanford University whose lab studies psychedelics.

Lykos’ CEO, Amy Emerson, added that many of the requests from the agency “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.” The FDA decision on MDMA could affect other drugs that are in the pipeline, like psilocybin and LSD, which are both considered “classic psychedelics” unlike MDMA.

“We will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”

The treatment had garnered considerable support from patients, leaders in the field of mental health and psychedelics and politicians from both parties. In recent weeks, advocates mounted a major public pressure campaign, emphasizing the dire need for new and effective treatments for veterans and the millions of people affected by PTSD.

Despite the drug company feeling vexed, the outcome of the hearing does not necessarily mean the US government is opposed to the idea of using psychedelics-assisted therapy, with many experts believing that they are just treading carefully.

Support for MDMA’s therapeutic potential has come from research scientists at top academic centres and even the US Department of Veterans Affairs. Naturally, they are disappointed in the FDA decision.

“The FDA’s decision is disgraceful,” said Heroic Hearts Project, a veterans organization that had lobbied for FDA approval citing the many veteran suicides in a statement.

“This is the epitome of bureaucratic red tape – and the result is people will keep dying.”

There has been a two-decade-long campaign to accept MDMA-assisted therapy as a valid treatment for PTSD. The early studies were led by researchers connected to the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, which also created the protocols that are incorporated into the treatment.

Lykos, supported by MAPS, was able to move on with bigger human studies and apply for approval from federal authorities as a result and raised more than $100 million (R1.8 billion) in anticipation of the FDA approving their MDMA medication. Much of this was raised on the back of successful trials held in 2022 which showed just over 70% of participants ‘no longer met the diagnostics criteria for PTSD’ after only three therapy sessions with MDMA.

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

With MDMA back on ice, pharmaceutical firms who make bank from the last few letters of the alphabet are likely terrified that psilocybin may now become the first psychedelic to receive FDA approval.

[source:npr]