FDA Rejects Potential PTSD Treatment

The U.S. Food and Drug Administration (FDA) declined to approve MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD).

“Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD,” CBS News reports.

“The FDA just kneecapped approval of MDMA. This is the highest efficacy / lowest side effect intervention for depression and PTSD ever studied. Helps those suffering get to root cause of trauma. But it’s not a recurring treatment. Against pharma business model,” Calley Means commented.

The FDA just kneecapped approval of MDMA.

This is the highest efficacy / lowest side effect intervention for depression and PTSD ever studied. Helps those suffering get to root cause of trauma.

But it’s not a recurring treatment. Against pharma business model.

Outrageous. https://t.co/bAOG6gsvuy pic.twitter.com/Zyl3OrOaZe

— Calley Means (@calleymeans) June 5, 2024

Per CBS News:

Lykos said the FDA asked for another phase 3 trial to study the safety and efficacy of MDMA.

“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,” Amy Emerson, the CEO of Lykos Therapeutics, said in a release.

Emerson said that conducting another phase 3 study, as requested by the FDA, “would take several years” to be done. Phase 3 trials are typically the final and largest stages of clinical studies that drugmakers conduct before seeking approval.

Lykos acknowledged that the concerns the FDA raised echoed those that were brought up by an advisory committee earlier this year. That panel had voted by a majority against the application over a number of concerns about the trials it had done so far.

The FDA’s rejection of MDMA as a PTSD treatment is a “blow to drug activists and veterans who’ve long campaigned for the psychedelic treatment,” STAT News noted.

“The FDA rejected MDMA for PTSD treatment because, and this is seriously the reason, those who were not in the placebo group could tell they were not the placebo group. What a joke. The FDA has approved some of the most evil, damaging ‘medications’ known to man. Someone doesn’t want to lose $$$,” Ashley St. Clair commented.

The FDA rejected MDMA for PTSD treatment because, and this is seriously the reason, those who were not in the placebo group could tell they were not the placebo group.

What a joke. The FDA has approved some of the most evil, damaging “medications” known to man. Someone doesn’t… https://t.co/A1DxyuBt4s

— Ashley St. Clair (@stclairashley) August 11, 2024

STAT News reports:

Existing therapies don’t work well for many of the estimated 13 million Americans with PTSD, and no new drug for the disorder has been approved in more than two decades.

Several members of MAPS previously said they were expecting FDA approval, and were unprepared for recent questions about data integrity. The ad comm rejection of the evidence from the two trials was a “gut punch,” MAPS executive director Kris Lotlikar said at a public webinar in July. “We’re still fighting a lot of deeply rooted stigma about psychedelics,” he said at the time. “Whatever the outcome, we’re just going to press forward and do whatever we can to make this happen.”

Boris Heifets, a neuroscience researcher at Stanford University who studies psychedelics, told STAT he was surprised at the FDA’s decision, adding he’d expected the agency would approve the drug with a requirement for post-approval studies. “PTSD is a major public health issue, and the only way you’ll get any traction is to throw out a little rope for investment in better treatments,” he said. “I was honestly expecting a more positive signal here … now we wonder, will FDA ever approve this stuff?”

The FDA, he noted, approved the depression treatment esketamine with far less convincing data than Lykos’ — and he suspects that if a bigger pharmaceutical company had run the trials, MDMA would have won approval.

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