FDA Won’t Approve Psychedelic MDMA for PTSD, Calls for More Research

WASHINGTON — Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a treatment for PTSD, a major step forward for groups seeking a landmark decision to support the use of the mind-altering substance to treat serious mental health conditions.

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

Lykos and other psychedelic companies had hoped MDMA would be approved and pave the way for other hallucinogenic drugs to enter the medical mainstream. If the FDA had granted 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 in May against using the drug to treat post-traumatic stress disorder. The negative vote came after a daylong meeting in which experts reviewed Lykos’ trial data, research methods and possible risks of the drug, including heart problems, injuries and misuse.

Lykos said the concerns expressed by the FDA in its so-called full response letter are consistent with those expressed by experts at the meeting.

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

Lykos is essentially a corporate spin-off from the leading U.S. psychedelic advocacy organization, the Multidisciplinary Association for Psychedelic Studies (MAPS), which funded the initial MDMA research with millions of dollars from wealthy donors.

The group pioneered research into the medical use of psychedelics that major pharmaceutical companies would not fund. Two small studies submitted to the FDA suggested that combining MDMA with talk therapy led to significant relief of PTSD symptoms.

Antidepressants are currently the only FDA-approved drugs to treat post-traumatic stress disorder, which is closely linked to depression, anxiety, and suicidal thoughts. It is more common in women and veterans.

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

But the FDA review has brought new scrutiny to the research: The vast majority of patients in the Lykos studies correctly guessed whether they were given MDMA or a dummy pill, making it “nearly impossible” to maintain the “blinding” that is considered essential in medical research, according to internal FDA officials.

Separate accusations of misconduct have emerged in recent months, including that some researchers involved in the trials encouraged patients to conceal negative results or exaggerate positive results.

Despite the setback, many experts believe other psychedelic substances may fare better with the agency.

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

The idea of using psychedelics to enhance psychotherapy isn’t new. A handful of therapists in California used MDMA in the 1970s and ’80s—when it was still legal—to facilitate couples therapy sessions. MAPS was founded in 1986 to challenge a federal decision to put MDMA in the same ultra-restrictive drug category as heroin, LSD, and other illegal psychedelics.

MAPS’s MDMA research for PTSD began more than a decade ago. Since then, dozens of small, startup drugmakers have entered the field, testing other substances, such as 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 companies, Compass Pathways and the Usona Institute, are conducting advanced research on psilocybin, the active ingredient in hallucinogenic mushrooms, as a treatment for major depression.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.