The agency’s advisory council made the decision in June after finding insufficient proof of the therapy’s safety or efficacy.
MDMA, sometimes referred to as ecstasy, was not approved by the Food and Drug Administration to treat PTSD, according to a statement released on Friday by the pharmaceutical company Lykos Therapeutics.
Proponents and experts agree that the ruling is a little setback for the expanding field of psychedelic therapy of specific mental health issues.
The FDA has been under tremendous political pressure to approve the medication. With Friday’s ruling, the government examined a Schedule 1 psychedelic for medicinal use for the first time. It would have been the first novel PTSD treatment in more than 20 years if it had been authorized.
Lykos Therapeutics had requested FDA approval to use the medication in conjunction with talk therapy as part of a treatment plan.
The government made its judgment in response to an independent advisory committee’s June rejection of the drug’s licensing recommendation, citing insufficient proof of the therapy’s efficacy and safety.
The committee raised a number of issues, such as studies that were not well planned, claims of sexual misbehavior during a clinical study that was in the middle of being conducted, and the possibility of major health hazards following medication usage, such as heart problems and misuse.
A handful of patients and therapists may have been able to determine who was given the medicine and who was given a placebo, according to an FDA scientists’ study that was released prior to the June conference and raised questions about how the studies were conducted.
Experts state that they anticipate FDA clearance for psychedelic medicines in spite of the refusal. ClinicalTrials.gov indicates that there are around forty MDMA experiments at varying stages of clinical development.
Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania, stated, “I think it will be a temporary setback.” “Lykos and other companies should know pretty clearly how to proceed going forward if they want to get psychedelics approved, as the advisory committee and FDA gave very clear indications of what they’re looking for in terms of study design and adverse event reporting.”
Examining psychedelics
The agency’s denial emphasizes the intense testing and scrutiny that proponents of psychedelics must go in order to get permission for medicinal usage in the United States.
Lykos claims that the FDA requested that the business finish a second phase 3 clinical trial in order to better examine the drug’s efficacy and safety. Lykos went on to say that the agency voiced worries that were similar to those brought up at the June meeting of the advisory group. The manufacturer said that it will request that the FDA review its ruling.
“In addition to all those who devoted their lives to this groundbreaking endeavor, the FDA’s request for additional research is extremely disheartening, especially for the millions of Americans suffering from PTSD and their families who have been without new treatment options for more than 20 years,” Lykos CEO Amy Emerson stated in a statement.
An FDA representative acknowledged in a statement that there is a “great need” for more PTSD therapy choices.nonetheless, “as discussed at the advisory committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication,” a spokesman stated.
Data presented by the FDA during the June conference indicates that around 13 million Americans, a large number of whom are veterans, suffer from PTSD.
The primary therapies are talk therapy and antidepressants; however, patients may not complete their prescribed course of treatment, and the FDA reports that fewer than one-third of patients have complete remission of their symptoms.
The FDA’s ruling, according to David Olson, head of the U.C. Davis Institute for Psychedelics and Neurotherapeutics, won’t stop psychedelics from being developed for mental health conditions like PTSD. He mentioned that the FDA has already authorized ketamine for the treatment of depression that is resistant to conventional treatments. Under the brand name Spravato, that version makes use of esketamine, a customized medication that lacks the dissociative and hallucinogenic properties of naturally occurring psychedelics.
In the upcoming five years, Olson anticipates the development of another psychedelic-based PTSD therapy.
“Groups developing psychedelics, like psilocybin, are showing a lot of promise. Hopefully, they will learn from past mistakes and be more rigorous,” Olson said in an email.
In addition, he mentioned a recently developed family of medications known as neuroplastogens, which he said were made to minimize adverse effects like hallucinations while maintaining the therapeutic benefits of MDMA.
“All of this indicates that this therapeutic class has a very bright future ahead of it,” he stated.
Despite the FDA’s ruling, Dr. Brian Barnett, a psychiatrist who oversees psychedelic research at the Cleveland Clinic in Ohio, expressed confidence that MDMA will eventually be authorized for the treatment of PTSD.
Barnett said, “It will be another arrow in the psychiatry quiver.” “There are effective therapies available for PTSD. However, they are not effective for everyone.
Although he pointed out that some of the concerns expressed by the FDA and the advisory group on the studies are not specific to MDMA, he accepted their worries.
“What was called functional blinding—where the participants knew whether they got MDMA or not—was very important to the advisory committee,” he added. “I found it quite surprising that they were concentrating so much on that, considering that functional blinding is an issue with practically all pharmaceutical treatments in psychology.”
Putting pressure on the FDA
Nearly 800 veterans wrote to President Joe Biden in July pleading for him to take MDMA treatment for PTSD into consideration. They expressed their “confident” belief that the therapy will prove to be “among the most invaluable treatments ever developed to combat the veteran suicide epidemic.”
Politicians discussed it as well.
Biden and FDA Commissioner Robert Califf received letters earlier this month from a bipartisan group of 80 senators pleading with them to take the treatment’s approval into consideration. The letters stated that “we cannot allow our veterans to continue to suffer in silence.”
Lynch, from the University of Pennsylvania, expressed her dismay at the lawmakers’ pressure on the FDA to make the judgment, saying it might have a negative impact on psychedelic approvals in the future.
While the agency’s choices cannot always be based only on scientific evidence and often include making “judgment” calls regarding safety and efficacy, the speaker noted that “when politicians interfere on behalf of specific products, it can reduce trust in FDA’s decisions.”
The nonprofit Institute for Clinical and Economic Review, which assesses the efficacy and cost of medications, has expressed disapproval of the treatment’s development, stating in a report that was released in late March that participants in the trial handled psychedelics “more like a religious movement than like pharmaceutical products.”
“We hope that ongoing and future careful research will examine how to maximize the benefits and minimize the harms of adding MDMA to these and other psychotherapies,” said Dr. David Rind, chief medical officer of ICER, in a statement released after the FDA’s approval.
