Breaking News: Federal regulators reject MDMA-assisted therapy for PTSD

Today Lykos Therapeutics announced that the Food and Drug Administration rejected its drug application to use MDMA-assisted therapy in the treatment of PTSD. The agency issued what’s called a Complete Response Letter to Lykos detailing its concerns and laying out what new information it would need from the company for an application resubmission.

The company says the agency has requested it conduct an additional phase 3 study. Such a clinical trial will likely take years to complete and Lykos says they will ask the FDA to reconsider. The Lykos press release also states that “the issues expressed in the CRL echo those raised during the FDA Advisory Committee meeting on June 4, 2024.” 

At that meeting, 9 of the 11 voting committee members said they did not feel the available data showed MDMA was effective in treating PTSD, and 10 said they did not feel the benefits of MDMA-assisted therapy outweigh the risks. The committee also raised concerns that the study did not adequately control for participants’ expectations, did not include measures to track the drug’s addiction potential, and that some participants have alleged misconduct and data suppression. Additionally, the committee pointed out that in the clinical trials, MDMA was used in conjunction with therapy, which the FDA does not regulate, and that the study’s design does not elucidate what role therapy itself may have played in the clinical trial results.

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For advocates, this was a crushing blow after two decades of work. MAPS first submitted an investigational new drug application for MDMA in 2001; a decade ago, the non-profit spun out a for-profit company, now called Lykos, to manage its clinical trials. Lykos filed a new drug application for MDMA in late 2023, and when the FDA accepted the application, they decided to give it an accelerated “priority review,” which the agency grants to drugs that could be “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.” 

Over the last few weeks, psychedelics advocates have been lobbying the government to approve MDMA in a myriad of ways.In mid-July, the Heroic Hearts Project, a organization that connects veterans with psychedelics resources, created a memorial in front of the U.S. Capitol that held 150,000 dog tags representing veterans who died by suicide since 9/11. The organization, along with a dozen other veterans organizations and 700 veterans and first responders, also sent a letter to President Biden, urging him to “foster cooperation across various departments and agencies to ensure all necessary resources are provided to unlock the full potential of MDMA-AT.” 

Representative Jack Bergman (R-MI), the highest-ranking combat veteran in the U.S. Congress, along with 80 representatives and senators, signed a similar letter to Biden, in which they “express our sense of urgency to address the post-traumatic tress disorder and suicide epidemic among Veterans and servicemembers, and the grave need for new and better treatment options like MDMA-assisted therapy.” 

Meanwhile, others have continued to raise concerns. Three clinical trial participants told the Wall Street Journal that they felt pressured to report positive outcomes, and that they experienced a worsening in their suicide ideation during and after the trials, but those outcomes weren’t captured in the final results of the study. 

The FDA does not publicly publish Complete Response Letters (CRL), as they could contain proprietary information, so the only details we currently have come from Lykos’s press release. (A 2015 paper published in BMJ points out that press releases often obscures details from CRLs.) Key questions remain about the FDA’s concerns with Lykos’s trials, but more information will likely emerge as Lykos navigates its next steps.