WASHINGTON — The U.S. Food and Drug Administration on Friday rejected approval of the psychedelic drug MDMA to treat PTSD, a major setback for groups seeking a landmark ruling in favor of using mind-altering substances to treat serious mental illness.
The pharmaceutical company Lykos Therapeutics said the FDA had informed the company that its drug “cannot be approved based on the data presented so far” and requested an additional, advanced-stage study. Such studies usually take several years and cost millions of dollars. The company announced that it would ask the agency for a new review.
Lykos and other psychedelic companies had hoped that MDMA would be approved, paving the way for other hallucinogenic drugs to enter the medical mainstream. Had the FDA approved the application, MDMA, also known as ecstasy or molly, would have become the first illegal psychedelic to receive federal drug approval.
The FDA’s decision had been expected after a panel of government advisers voted overwhelmingly against the drug’s use in post-traumatic stress disorder in June. The no vote came after a day-long meeting in which experts scrutinized Lykos’ trial data, research methods and potential risks of the drug, including heart problems, injuries and misuse.
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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 the proposed indication.” The agency said it will continue to encourage “innovations for psychedelic treatments and other therapies to meet these medical needs.”
Lykos said the FDA’s issues raised in a so-called Complete Response Letter reflected concerns raised during the June meeting.
“The FDA’s request for another study is deeply disappointing,” Lykos CEO Amy Emerson said in a statement Friday. “We are heartbroken for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others who suffer from PTSD and may now face additional years without access to new treatment options.”
Lykos is essentially a spin-off of the country’s leading psychedelics advocacy group, the Multidisciplinary Association for Psychedelic Studies (MAPS), which funded the first studies on MDMA by raising millions of dollars from wealthy donors.
The group pioneered research into the medical use of psychedelics, which big pharmaceutical companies refused to fund. Two small studies submitted to the FDA suggested that combining MDMA with talk therapy resulted in significant relief of PTSD symptoms.
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Antidepressants are currently the only FDA-approved medications for PTSD, which is closely linked to depression, anxiety and suicidal thoughts and is more common in women and veterans.
In recent years, MDMA research has been widely publicized by veterans, who say the lack of treatments for the disease has contributed to higher suicide rates among service members. Last month, veterans who support psychedelic therapies gathered on Capitol Hill to promote the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks calling for MDMA to be approved.
But the FDA’s review put the research in a new light. The vast majority of patients in Lykos’ studies correctly guessed whether they had received MDMA or a placebo pill. According to FDA officials, this made it “virtually impossible” to maintain the “blinding” that is considered essential to medical research.
Several allegations of misconduct have surfaced in recent months, including claims that some researchers involved in the studies instructed patients to suppress negative results or inflate positive ones.
Despite the setback, many experts say other psychedelics might fare better with the agency.
MDMA is the first of a number of psychedelic drugs expected to be reviewed by the FDA in the coming years amid renewed 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 protest a federal decision that placed MDMA in the same extremely restrictive drug category as heroin, LSD and other illegal psychedelics.
MAPS’ studies on MDMA began more than a decade ago. Since then, dozens of small, start-up pharmaceutical companies have entered the field, studying other substances like psilocybin and LSD for conditions like depression, addiction and anxiety. These studies are generally more extensive and rigorous than the MDMA studies submitted to the FDA.
Two drug developers, Compass Pathways and Usona Institute, are conducting advanced studies on psilocybin – the active ingredient in magic mushrooms – to treat severe depression.
