The US Food and Drug Administration (FDA) on Friday refused to approve an MDMA-based drug for the treatment of post-traumatic stress disorder (PTSD), its manufacturer announced, in a major setback for the medicinal use of psychedelic drugs.
The pharmaceutical company Lycos Therapeutics The FDA told them The treatment “cannot be approved based on the data submitted to date.”
Lycos said the FDA has requested additional Phase 3 trials to further study the treatment’s safety and effectiveness, but those studies often take years. The company said it plans to request a meeting with the FDA and ask for a reconsideration.
“The FDA’s request for new studies is disappointing not only for all those who dedicated their lives to this pioneering work, but also for the millions of Americans living with PTSD and their families who have been without new treatment options for more than two decades,” Lycos CEO Amy Emerson said in a statement.
The decision was widely expected after an independent FDA advisory committee overwhelmingly recommended not approving a treatment that combines MDMA, commonly known as ecstasy, with talk therapy to treat PTSD.
The committee questioned the reliability of the trials studying the treatment, noting that agency officials in particular noted that patients taking part in the trials could guess whether they were receiving MDMA or a placebo, making it virtually impossible to “blind” the studies.
They praised the treatment’s promise but said the risks far outweighed the benefits, expressed concern that the manufacturers’ scientific research had been influenced by the psychedelic promotion efforts of the parent organization, the Association for Multidisciplinary Psychedelic Research, and questioned whether serious adverse events were adequately tracked during the trials.
“While repeat Phase 3 trials would take several years, we continue to maintain that many of the requests raised in previous discussions with the FDA and advisory committee meetings can be addressed through existing data, post-approval requirements, or references to the scientific literature,” Emerson said.
The decision sparked an enormous lobbying effort from advocacy groups, including combat veterans. Earlier this week, a bipartisan group of more than 80 House and Senate members sent a letter to the FDA and the White House urging approval.
The FDA has not approved a new treatment for PTSD in more than 20 years, and advocates say the government needs to do more to protect veterans because suicide rates among veterans remain high.
A growing body of research is showing that hallucinogens like LSD, psilocybin mushrooms, and MDMA can have a significant positive impact on conditions like PTSD.
The application marks the first time the United States has considered a Schedule I drug, such as heroin or LSD, which have a high potential for abuse, for medical use.
The National PTSD Center estimates that more than 13 million people in the United States suffer from PTSD, with veterans disproportionately affected, but current treatments are notoriously ineffective.
