WASHINGTON – Federal health regulators on Friday refused to approve the psychedelic drug MDMA as therapy for PTSD, a major setback for groups seeking an innovative decision in favor of using mind-altering substances to treat serious mental health problems.
Drugmaker Lykos Therapeutics said the FDA notified the company that its drug “could not be approved based on the data presented to date” and requested an additional late-stage study. Such studies typically take several years and millions of dollars to conduct. 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 granted the request, MDMA, also known as ecstasy or molly, would have become the first illegal psychedelic to become a federally approved medication.
The FDA’s decision was expected after a panel of Government advisers voted overwhelmingly against the use of the drug for post-traumatic stress disorder in June. The negative vote came after a meeting that lasted an entire day, in which experts examined data from Lykos’ studyresearch methods and possible risks of the drug, including heart problems, injuries and abuse.
The FDA said Friday that the MDMA application had “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 “innovation in psychedelic treatments and other therapies to meet these medical needs.”
Lykos said the issues raised by the FDA in what is called a complete response letter echoed concerns during the June meeting.
“The FDA’s request for another study is deeply disappointing,” Lykos CEO Amy Emerson said Friday in a statement. “Our hearts break for the millions of military veterans, first responders, victims of sexual and domestic abuse, and countless others suffering from PTSD who may now face years more without access to new treatment options.”
Lykos is essentially a corporate spinoff of the country’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which financed early MDMA studies by raising millions of dollars from wealthy backers.
The group has been a pioneer in investigating the medical use of psychedelic substances, which major pharmaceutical companies have been unwilling to fund. Two small studies submitted to the FDA suggested that combining MDMA with psychotherapy led to significant relief of PTSD symptoms.
Antidepressants are now the only FDA-approved medications for PTSD, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans.
In recent years, research into MDMA has been widely publicized by combat veteranswho claim that a lack of treatment options for the disease has contributed to higher rates of suicide among military personnel. Last month, veterans who support psychedelic therapy rallied at the Capitol in support of the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks calling for MDMA’s approval.
But the FDA review brought new scrutiny to the investigation. The vast majority of patients in the Lykos studies correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain “blinding,” which is considered essential to medical research, according to FDA internal officials.
In recent months, separate allegations of misconduct have emerged, including that some investigators involved in the studies coached 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 psychedelics which are 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. Some therapists in California used MDMA during the 1970s and 1980s — when it was still legal — to facilitate couples therapy sessions. MAPS was founded in 1986 to oppose a federal ruling that placed MDMA in the same ultra-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 pharmaceutical start-ups 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 Usona Institute, are conducting late-stage studies of psilocybin – the active ingredient in magic mushrooms – for severe depression.
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