The U.S. Food and Drug Administration (FDA) rejected on Sunday a request by a pharmaceutical company to approve MDMA (commonly known as Ecstasy) as a treatment for post-traumatic stress disorder (PTSD). The decision follows recommendations by the agency's advisory committee held in June, which concluded there wasn't enough evidence to prove that the treatment was safe or effective.
Lykos Therapeutics, the company behind the treatment, announced last Friday the FDA had decided not to approve their therapy. However, various experts believe the future of using psychedelic substances to treat certain mental health conditions remains promising.
NBC reported that the FDA faced intense political pressure to approve the drug. Had it been approved; it would’ve marked the first new treatment for PTSD in over two decades. Lykos Therapeutics had sought FDA approval for the drug as part of a therapy protocol that included counseling sessions.
The approval would have made MDMA the first psychedelic substance regulated by U.S. authorities. The decision is a disappointment for many researchers and patients who were hopeful for advancements in PTSD treatment.
The FDA advisory committee highlighted several concerns, including allegations of inappropriate sexual behavior during a clinical trial and the potential for severe health risks after taking the drug, such as heart problems and dangers of misuse.
An FDA scientific review, published before the advisory committee meeting, also raised concerns about how the trials were held, including the possibility that some patients and therapists could have pointed out who received the drug and who received a placebo.
Despite the rejection, experts anticipate that more psychedelic treatments will seek FDA approval. There are approximately 45 MDMA trials in various stages of clinical development. "I think it will be a temporary setback," said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania.
"The advisory committee and FDA gave very clear indications of what they’re looking for in terms of study design and adverse event reporting, so Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved.”
According to Lykos, the FDA has requested that the company complete an additional phase 3 clinical trial to further investigate the drug's safety and efficacy. Lykos said it plans to ask the FDA to reconsider its decision.
"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," Lykos CEOM Amy Emerson said in a press release.
An FDA spokesperson acknowledged the "great need" for additional treatment options for PTSD. However, "as discussed at the advisory committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”
According to data shared by the FDA, about 13 million people in the U.S. suffer from PTSD, many of them military veterans. Many also require treatment for PTSD in Israel as well, a condition that has significantly worsened after October 7.
Counseling and antidepressants are the primary treatments offered for PTSD , but many patients don’t adhere to the treatment, and only less than a third report full remission of their symptoms due to medication use, according to the FDA.