FDA rejects MDMA treatment for PTSD in 'speed bump' for psychedelics

The FDA has rejected the use of MDMA as a treatment for post-traumatic stress disorder. 

Lykos Therapeutics, the company that developed the treatment, said in an Aug. 9 news release the FDA requested another Phase 3 trial to study the effectiveness of MDMA, also known as ecstasy, in treating PTSD. 

Final trials conducted by Lykos showed MDMA was effective in reducing PTSD symptoms when used alongside talk therapy. An FDA advisory panel expressed concerns with the validity of the drug's clinical trials. 

In June, the panel voted 9-2 that the treatment was not shown to be effective for treating PTSD, and 10-1 that the benefits of the treatment do not outweigh the potential risks. 

Lykos plans to ask the FDA to reconsider its decision, according to the news release. 

Amy Emerson, CEO of Lykos, said the FDA's request for another trial is "deeply disappointing." 

"While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature," she said. 

Lawmakers had pressed the FDA to approve the treatment. At least 80 Congresspeople signed letters urging the FDA to approve the treatment, according to Politico

Heroic Hearts Project, a veterans advocacy group that lobbied for MDMA treatment, called the FDA's decision "a missed opportunity to embrace groundbreaking science" in an Aug. 9 statement. 

"This is the epitome of bureaucratic red tape – and the result is people will keep dying," the organization said. 

Brian Barnett, MD, clinical director of Cleveland Clinic's psychiatric treatment resistance program, told Becker's the FDA raised concerns with a lack of clinical data on the cardiac and liver risks associated with the drug, and its potential for misuse. 

"These are kind of surprising — these are basic things. You assume they would have gathered these data," he said. 

Dr. Barnett is a consultant for companies developing psychedelic treatments, including CB Therapeutics and Compass Pathways. He was not involved with Lykos' treatment. 

Cleveland Clinic is conducting clinical trials of both psilocybin and LSD for behavioral health conditions.  

Because a new Phase 3 trial of MDMA-assisted treatment could take two to three years, psilocybin-assisted treatment could become the first psychedelic to gain FDA approval, Dr. Barnett said. 

Because most of the issues the FDA raised are "very particular" to Lykos's clinical trials, other biotech companies developing psychedelic treatments will persist, Dr. Barnett said. 

"I think people within the field are certainly going to be nervous after this, and potentially investors as well," Dr.  Barnett said. "But I think this is more of a speed bump than the end of the road for psychedelic research."

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