A panel of advisers to the Food and Drug Administration (FDA) recommended against the use of midomafetamine (MDMA) in conjunction with therapy, which has gained momentum in the veteran community. The committee voted 10-1 against the overall benefits of MDMA in the treatment of post-traumatic stress disorder (PTSD) on Tuesday.
The committee called into question the efficacy of the research presented to the FDA and claimed it was flawed and could have skewed the results. Several raised concerns over missing follow-up data on patient outcomes and a lack of diversity in the trial group.
“The FDA interrupted the conversation that the [advisory committee] was having and said that, one, the trial participants fit within the guidelines of the diversity that needs to be in an FDA trial, and two, this is not something you need to be taking into consideration,” Mercer said.
The decision comes just months after Congress approved $20 million for the U.S. Department of Veterans Affairs to begin MDMA-assisted therapies; VA researchers have conducted small study groups and will report their findings soon. Juliana Mercer, a Marine Corps veteran and a strong advocate for MDMA-assisted therapy, is the director of public policy for the nonprofit organization Healing Breakthrough.
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She was disappointed by many of the points the committee made during the 9-hour hearing.
“This was an unprecedented hearing. The [advisory committee] seems to have made a decision based off of ethics and integrity, scare tactics, and drug abuse, as opposed to facts and data,” Mercer said. “I think the FDA saw that. I think they were just as surprised as everybody else was.”
Lykos Therapeutics is the company presenting MDMA capsules to be used in conjunction with psychotherapy as a cure for PTSD. The FDA does not have to follow the committee’s ruling, and Lykos Therapeutics will have to answer and dispel some of the concerns raised during the hearing by Aug. 1, when the FDA will make its final ruling.
Over 2 million veterans suffer from PTSD, contributing to a suicide epidemic where hundreds take their own lives every month. According to the VA’s latest report detailing statistics from 2021, suicide was the 13th-leading cause of death for veterans overall; though the numbers are dramatically higher for veterans over 45 years old, being the number two cause of death.
Mercer said Lykos has an uphill fight on their hands and feels the committee’s debate over the drug shows they did not listen to the facts presented by the FDA at the start of the hearing.
“We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system if approved,” Amy Emerson, Chief Executive Officer of Lykos Therapeutics, said in a statement. “We are grateful to the advocates, clinical trial participants, and people living with PTSD who shared their testimony in the open public hearing and through written comments, and will continue to do everything we can to bring this potential new therapeutic option to people living with PTSD.”
In Lykos’ research, 71% of participants experienced resolution of their PTSD symptoms after three eight-hour MDMA-assisted therapy sessions, while 87% saw improvement in their symptoms.
“The longer we push this out, the more veterans are going to die. […] It’s gut-wrenching that the light that we were seeing at the end of the tunnel just got smaller. We have to wage an all-out war,” Emerson said.
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