The FDA rejects the psychedelic drug MDMA as a treatment for PTSD

Drugmaker Lykos Therapeutics said the FDA notified the company that its drug “could not be approved based on the data submitted to date” and requested an additional late-stage study. Such studies generally take several years and millions of dollars. The company said it plans to ask the agency to reconsider.

Lykos and other psychedelic companies hoped that MDMA would be approved and pave the way for other hallucinogenic drugs to enter the medical mainstream. If the FDA had accepted the request, MDMA, also known as ecstasy or molly, would have become the first illegal psychedelic to become a federally approved drug.

The FDA’s decision was expected after a panel of government advisers voted overwhelmingly against the drug’s use for post-traumatic stress disorder in June. The negative vote came after a day-long meeting where experts reviewed Lykos’ study data, research methods and the drug’s possible risks, including heart problems, injuries and abuse.

The FDA said Friday that the MDMA application has “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for its proposed indication.” The agency said it would continue to encourage “innovation for psychedelic and other therapies to address these medical needs.”

Lykos said the issues raised by the FDA in what is called a full response letter reflect concerns during the June meeting.

“The FDA’s request for another study is deeply disappointing,” Lykos CEO Amy Emerson said in a statement Friday. “Our hearts break for the millions of military veterans, first responders, victims of sexual and domestic abuse, and the countless others suffering from PTSD who may now face many years without access to new treatment options.”

Lykos is essentially a corporate spin-off of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which financed the initial studies of MDMA by raising millions of dollars from wealthy backers.

The group pioneered research into the medical use of psychedelics, which big pharmaceutical companies did not want to fund. Two small studies submitted to the FDA suggested that combining MDMA with talk therapy resulted in significant relief of PTSD symptoms.

Antidepressants are now the only FDA-approved medications for PTSD, which is closely related to depression, anxiety and suicidal thinking and is more prevalent among women and veterans.

In recent years, MDMA research has been widely publicized by combat veterans, who say a lack of treatment options for the condition has contributed to higher suicide rates among military personnel. Last month, veteran advocates of psychedelic therapy rallied on Capitol Hill in support of the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks asking for MDMA’s approval.

But the FDA review brought new scrutiny to the research. The vast majority of patients in Lykos’ studies correctly guessed whether they received MDMA or an inactive pill, making it “almost impossible” to maintain “blinding,” which is considered essential for medical research, according to FDA internal staff.

Separate allegations of misconduct have emerged in recent months, including that some researchers involved in the trials instructed patients to suppress negative results or inflate positive ones.

Despite the setback, many experts say other psychedelics may fare better before the agency.

MDMA is the first in a series of psychedelic substances expected to be reviewed by the FDA in the coming years as part of a resurgence of interest in their therapeutic potential.

The idea of ​​using psychedelics to enhance psychotherapy is not new. A handful of therapists in California used MDMA in the 1970s and 1980s—when it was still legal—to facilitate couples therapy sessions. MAPS was founded in 1986 to oppose a federal decision placing MDMA in the same ultra-restrictive drug category as heroin, LSD and other illegal psychedelics.

The MAPS studies of MDMA began more than a decade ago. Since then, dozens of small startup drugmakers have entered the field, studying other substances like psilocybin and LSD for conditions like depression, addiction and anxiety. These studies are generally larger and more rigorous than the MDMA studies submitted to the FDA.

Two drug developers, Compass Pathways and the Usona Institute, are conducting late-stage studies of psilocybin — the active ingredient in magic mushrooms — for severe depression.

View the new Fortune 50 Best Places to Live for Families list. Discover the top 2024 US destinations for multigenerational families to live, thrive and find community. Explore the list.