100 Percent Fed Up By Danielle
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…
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