Problems Plague MDMA Approval Process

Introduction to MDMA for PTSD

Currently, only‍ two drugs are officially approved for treating post-traumatic stress disorder (PTSD). However, some patients are ​turning ⁣to MDMA, also known as ecstasy, to alleviate their symptoms when traditional treatments fail.

Growing Momentum⁤ for Legalization

In the United States, there is increasing support for the legalization of‍ MDMA and other psychedelics. Lykos Therapeutics has ⁣been conducting clinical trials combining MDMA with psychotherapy to treat PTSD. This week, they had an opportunity to demonstrate the effectiveness of this ⁢combination.

Concerns and Criticisms

Despite the ⁣promising​ results, there are concerns about the‍ trials. Some participants had prior experience with MDMA, which could bias their reports.⁤ Experts also ⁣questioned the duration of symptom relief and the monitoring⁤ of side effects.

FDA’s Upcoming​ Decision

The​ FDA is expected ⁤to decide by⁤ August⁢ 11 on the approval of MDMA combined with psychotherapy for PTSD. While the agency often follows advisory committee recommendations, ‌approval is‌ not⁢ guaranteed. If approved, it would mark a significant milestone for psychedelics, which have‌ been ‌banned ⁤since the 1970s.

“I absolutely agree that we ⁣need new and⁤ better treatments for PTSD,” said committee member ⁢Paul Holtzheimer, deputy director for ‌research at the National‍ Center ⁢for PTSD, ⁢at‌ the meeting. “However,⁢ I also note ⁣that premature⁣ introduction of a treatment can actually stifle development and stifle ⁤implementation and lead to premature​ adoption of treatments that are either not completely known to be safe, not‌ fully effective,​ or not being used at their optimal efficacy.”

Reactions⁢ from Advocates

Advocates for MDMA-assisted therapy ⁤were disappointed by the committee’s recommendation. Juliana Mercer, director of veteran advocacy and public policy⁢ at Healing ⁢Breakthrough, emphasized the urgent need for new solutions to the veteran suicide epidemic.

“My life ⁣was saved ⁢by psychedelic-assisted therapy,”⁤ says Juliana Mercer, director‍ of veteran​ advocacy ‍and public policy at Healing Breakthrough, a nonprofit working to make MDMA-assisted therapy available‍ to veterans with PTSD. “I think ‌they ⁢lost the big picture as to why we need ⁢this. We don’t have another solution to the veteran suicide​ epidemic.”

Data and Trials

The committee’s decision was based on data ​from two ​trials involving nearly 200 individuals with PTSD. Lykos, a spinoff of the Multidisciplinary ⁣Association for Psychedelic Studies, has been working to legalize MDMA since 1986. One study showed significant symptom reduction, but the potential for bias was noted.

Therapy Variability

Another issue is the variability in ‍the psychotherapy administered during​ the trials. Participants had‍ eight-hour sessions ‍with two therapists, but ⁣the ⁣approaches ‍varied. This raised questions about how much of the outcomes were ​due to​ the drug versus the therapy.

Natalie Gukasyan, an assistant professor of psychiatry at ⁤Columbia ‌University who studies psychedelics,⁣ says “there’s a​ lot of wiggle⁢ room” in the Lykos manual ​on how the therapy​ session can be⁢ conducted.​ “If the treatment is medication-assisted psychotherapy,‌ maybe a little bit more of a prescribed therapy is appropriate,” she says.

Standardization and Safety

The FDA ‌does not regulate therapy or ⁤credential psychotherapists, raising questions about standardization. Gukasyan expressed concerns about Lykos training therapists, which ​could present a conflict‌ of interest.

Mixed​ Experiences

While some participants⁤ reported positive experiences, others had negative ones. Meaghan‍ Buisson testified about a troubling incident during her ⁣trial,⁤ which was also reported by New York Magazine. Another participant,​ Sarah ⁣McNamee, ⁣felt pressured to‌ report ⁤positively‍ about her experience.

Additional Concerns

Committee members noted missing ‌data on MDMA’s effects on liver function and potential‍ abuse‍ post-trial. These concerns were echoed in a report by​ the Institute for Clinical ‌and ⁤Economic Review, which questioned the validity of the trial results.

Lykos’ Response

Lykos‌ stands by⁣ its research, stating that many patients showed meaningful benefits. Kelley O’Donnell ​from the NYU‌ Langone Center‌ for Psychedelic Medicine ​observed visible improvements in patients.

“In many ways we’re ⁢creating a new field of medicine,” ⁢said Lykos’ senior medical director, Alia Lilienstein, in Tuesday’s meeting. But in order for​ patients to benefit, Lykos and other companies will first have to prove that‌ they actually work.

Looking Forward

In a statement after the meeting, ​Lykos ​CEO Amy Emerson said the company is committed to finding a path forward‌ and is working with the FDA to address outstanding questions. The FDA’s decision will be crucial in determining ‌the future⁣ of MDMA-assisted⁤ therapy ⁤and other‌ psychedelic treatments.