MDMA-assisted therapy backers say FDA panel ‘dead wrong’ to reject application

A Food and Drug Administration panel’s surprising recommendation this week to reject the use of MDMA, known as ecstasy, to treat PTSD, was a blow to activists and lawmakers who advocate for the treatment as a revolution in American mental health.

The FDA granted MDMA-assisted therapy “breakthrough therapy” designation in 2017 and is considering Lykos Therapeutics’ application for approval of its proposed treatment for PTSD.

The proposed treatment would be 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, and if approved, it would be the first new treatment for PTSD in decades.

“I am disappointed that the FDA advisory committee ignored the voices and testimony of veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who seek to discredit this promising treatment at all costs,” Rep. Jack Bergman (R-Mich.), a former Marine Corps Lt. Gen., told The Hill.

The committee voted 10 to 1 against the question of whether the risks outweigh the benefits, and 9 to 2 against its effectiveness. The committee’s recommendation is non-binding, and the committee is scheduled to make a final decision on the treatment by Aug. 11.

Rep. Lou Correa (D-Calif.) called the committee’s decision “completely wrong.”

“This is the first treatment that’s expected to revolutionize psychiatric care in 50, 60 years, and to say no to that? Are you kidding me?” Correa, who co-chairs the Congressional Psychedelic Therapy Caucus with Bergman, told The Hill in an interview.

A recent phase 3 clinical trial conducted by Lycos showed the treatment was 71 percent effective for PTSD, but an independent advisory committee expressed concerns about several issues, including the diversity of study participants, potential side effects, and the feasibility of conducting a “blinded” study of psychedelic drugs.

“Midomphetamine produces profound changes in mood, sensation, suggestibility, and cognition. As a result, blinding studies is nearly impossible,” the committee wrote. Briefing Document “Functional unblinding has the potential to introduce bias into clinical studies,” a report posted ahead of the meeting said.

Several panelists said they were excited by the initial results but felt the drug was too experimental.

“While we are disappointed with the outcome of the vote, we will continue to cooperate with the FDA’s ongoing review,” Lycos CEO Amy Emerson said in a statement after the vote. “New effective, accessible treatments are urgently needed to address the unmet needs of people living with PTSD.”

Ahead of the committee’s recommendation on Tuesday, Bergman and Correa celebrated the unanimous addition of two amendments to a federal spending bill calling on the Department of Veterans Affairs (VA) to expand and prioritize research into MDMA-assisted therapy, training and a plan for implementing the treatment if approved.

Speaking at the Horizons Psychedelics conference in New York City last month, Veterans Affairs Under Secretary of Health Sherif Elnahar said the research findings on the use of MDMA to treat PTSD “speak for themselves.”

“Here’s the reality: The evidence-based treatments that we have for conditions like PTSD, particularly the unique symptoms of PTSD in veterans, while effective, pale in comparison to whether we can replicate the preliminary results that we’ve seen with psychedelics, particularly MDMA for PTSD, and psilocybin for treatment-resistant depression, and that’s why I’m here,” Elnahal said.

Juliana Mercer, director of veterans advocacy and public policy at Healing Breakthrough, told The Hill that she woke up with a sick feeling in her stomach after the verdict was handed down.

Healing Breakthrough is an advocacy group working to promote MDMA-assisted therapy for veterans with PTSD. With more than 6,000 veterans committing suicide each year, Mercer said the drug offers real hope to veterans suffering from PTSD.

“The knot cannot be undone, [a] “This is heartbreaking for all of our veterans who have been waiting for this as a hope and a light at the end of the tunnel after decades of pain. Veterans who were on waiting lists for deportation and who had hope that help would be available soon, we are devastated,” Mercer said.

The proposed treatment would help more than just veterans, advocates and lawmakers said. VA It is estimated that 5 percent of people PTSD affects 13 million people in the United States each year, and in 2020, about 13 million Americans had PTSD.

Mercer said it was a “moral imperative” to help people suffering get access to medication, a sentiment echoed by Correa.

“We’re not saying we know this is a game changer. We know it is a game changer,” Correa said.

Despite the setback, Bergman said he remains “confident that this is merely a hitch in our overall effort to truly heal the invisible wounds suffering from millions of Americans today.”