A potential treatment for post-traumatic stress disorder using the psychedelic MDMA was overwhelmingly rejected by a panel of federal regulators on Tuesday, in what could be a major setback for the use of psychedelics in treating mental illness.
The Food and Drug Administration (FDA) panel voted 10-1 against endorsing the safety of MDMA in treating PTSD, and 9-2 against its efficacy. The group cited flawed studies, inconclusive data and potential for harmful side effects.
The FDA is not required to follow the panel's recommendation on whether or not to approve the use of MDMA, although the thorough criticism could be used as a reason to reject the treatment.
“It seems like there are so many problems with the data – each one on its own may be fine, but when you stack them on top of each other… I would just have a lot of questions about how effective the treatment is,” one panel said. member Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.
Tuesday's panel meeting marked the first time the use of a Schedule 1 psychedelic drug for medical use was ever considered. MDMA treatment could be the first new treatment for PTSD in decades.
Lykos Therapeutics, the company behind the treatment, is backed by the country's leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies. It said in one rack that it will work with the FDA to seek approval in the future.
“We are disappointed with today's vote given the urgent unmet need in the field of PTSD and appreciate that the committee was faced with a challenging and atypical task, namely to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” wrote CEO Amy Emerson.
The FDA panel specifically raised concerns about the diversity of the subjects of the studies and the replicability of the results. The panel noted that because MDMA is a psychedelic drug, patients could easily determine whether they were receiving a placebo dose, making the study “blinding” impossible.
The psychedelic nature of the drug also made its specific effects harder to track due to the generic, hard-to-describe nature of the drug. MDMA does not cause hallucinations like other psychedelics, but rather alters a person's emotions.
MDMA treatment group Healing Breakthroughs strongly criticized the panel's vote, saying regulators had “missed the forest for the trees.”
“Six thousand veterans have died by suicide every year since 9/11,” Juliana Mercer, director of the group, said in a speech. rack. “This is a heartbreaking statistic that has remained unchanged despite billions of taxpayer dollars and countless treatments that have proven ineffective in ending the suicide epidemic.”
The Lykos study, which was criticized by the panel, found that MDMA treatment was about 71 percent effective for PTSD.
“Delaying the FDA's approval of MDMA-AT undermines the hopes of millions of suffering Americans
of PTSD,” Healing Breakthrough warned in a statement. “It also means that this year, and every year, more veteran lives will be needlessly lost to suicide until this therapy is approved.”
The FDA is expected to make a final decision on the treatment on August 11.
