A potential treatment for post-traumatic stress disorder using psychedelic MDMA was overwhelmingly rejected by a panel of federal regulators on Tuesday, marking 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 MDMA’s safety in treating PTSD and 9-2 against its effectiveness. The group cited flawed studies, unclear data and the potential for harmful side effects.
The FDA is not required to follow the panel’s recommendation regarding approval of the use of MDMA, although the thorough criticism may be used as a justification for rejecting the treatment.
“It seems like there are a lot of problems with the data – each on its own might be good, but when you stack them on top of each other… there are a lot of questions I would have about the effectiveness of the treatment,” the panel said. member Dr. Melissa Decker Barone, a psychologist with the Department of Veterans Affairs.
Tuesday’s panel meeting was the first time consideration was given to using a Class 1 psychedelic drug for medical use. 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. Said in one declaration which will work with the FDA to obtain approval in the future.
“We are disappointed with today’s vote given the urgent unmet need in PTSD and recognize that the committee faced a challenging and unusual task, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” the CEO wrote. Amy Emerson.
The FDA panel specifically noted concerns about the diversity of study subjects and the replicability of their results. The panel noted that because MDMA is a psychedelic, patients could easily determine whether they received a placebo dose, making the “blind” study impossible.
The psychedelic nature of the drug has also made its specific impacts more difficult to track due to the drug’s difficult-to-describe general nature. MDMA does not cause hallucinations like other psychedelics do, but it does alter a person’s emotions.
MDMA treatment advocacy group Healing Breakthroughs extensively 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, the group’s director of veterans advocacy, said in a statement. declaration. “This is a harrowing statistic that has remained unchanged despite billions of taxpayer dollars and a myriad of treatments that have proven ineffective in ending the epidemic of veteran suicides.”
The Lykos study, criticized by the panel, found that MDMA treatment was about 71% effective for PTSD.
“Delaying FDA approval of MDMA-AT dashes the hopes of millions of Americans who suffer
of PTSD,” warned Healing Breakthrough in a statement. “It also means that more veterans’ lives will be needlessly lost to suicide this year, and every year, until this therapy is approved.”
The FDA is expected to issue its final decision on the treatment by August 11.
This story originally appeared on thehill.com read the full story
