FDA rejects MDMA-assisted therapy for PTSD

The US Food and Drug Administration did not greenlight the use of MDMA popularly referred to as ecstasy, as a treatment for post traumatic stress disorder, Lykos Therapeutics stated on Friday. 
 
Evidently, the health experts and activists in the field of psychedelic use for combating mental health disorders regard the decision as a minor blow in the ongoing campaign in the compassionate use of psychedelics. 
 
This had come as pressure from the political scene with calls for the FDA to approve the drug. On Friday, the agency made the first attempt to evaluate Schedule 1 psychedelic for medical use. It would have been the first new treatment for PTSD approved in more than two decades, in case it was approved. 
 
Lykos Therapeutics had sought FDA approval for the drug ENTYVNOX as an adjunct to talk therapy in treatment regimen. 
 
The agency move followed in June an independent advisory committee’s refusing to endorse the therapy because it claimed that there had been no adequate evidence to support the drug’s safety and efficacy. 
 
The committee listed a number of concerns that they attributed to the poor quality of the studies, sexual misconduct which was reportedly to have happened in the middle of clinical trial and danger signs that include heart issues and substance dependency among those who took the drug. 
 
Another scientific review posted prior to the June meeting also questioned the conduct of the trials, the core aspects of which included that patients and therapists probably could tell which people received the drug and which received the placebo. 
 
Psychedelics for therapy seem to have faced a dead-end, as the FDA rejected requests for the approvals of psilocybin and other psychedelic compounds; however, the experts believe that they will soon be approved after all. So, the site ClinicalTrials indicates there are approximately four dozen MDMA trials on different phases of clinical. gov. 
 
“I think it will be a temporary setback,”consumedHolly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania. “The advisory committee and the FDA provided very clear signals of what they expect investors and researchers to deliver in terms of study design and adverse event reporting so Lykos and other wannabe approved psychedelics manufacturing companies know exactly how it’s done if they are inclined to do so from albeit a different angle”. 
 
Psychedelic scrutiny 
 
The agency’s rejection points out the various steps and intense evaluation psychedelics must go through while advocates are pushing for their approval in the U. S for medical use. 
 
As Lykos pointed out, in the original plan, the FDA asked the company to conduct an extra phase 3 clinical trial for the drug safety and efficacy. Lykos said the agency made similar sentiments that were made during the advisory committee meeting in June. Merck said it will seek a new review of its application from the FDA. 
 
“This is bitterly disappointing, not only for everyone at Lykos who has spent their entire professional lives developing this groundbreaking approach, but for the millions of Americans with PTSD, and their families, who have no substantially new treatment available to them after twenty-two years, in courtesy of the FDA,” Amy Emerson, the Lykos CEO stated. 
 
In a statement, the FDA stated that they understood the “large unmet medical need” that is associated with PTSD sufferers finding new and effective forms of treatment. 
 
Nonetheless, the agency “as was mentioned during the advisory committee meeting” cannot state that that the respective drug is safe and efficient for the proposed use since there are severe limitations to the data included into the application. 
 
At the June meeting, the FDA disclosed that about 13 million people in the U. S with PTSD of which many are veterans. 
 
The primary treatments include talk therapy and antidepressants, however, patients may not always adhere to therapy services and approximately one third report complete remission of their symptoms when taking the medications, as stated by the FDA. 
 
David Olson, the director of the U. C. Davis Institute for Psychedelics and Neurotherapeutics stated that he doubted the FDA decision, could slow the progress of using psychedelics in mental health disorders such as PTSD. He said that there is a version of ketamine that has been licensed for treatment resistant depression. That version marketed under the name Spravato uses a compound called esketamine which unlike naturally occurring psychedelics has different effects, and lacks dissociative and psychedelic properties. 
 
Olson feels that within the next five years, there could be another psychedelic treatment for PTSD. 
 
“Compounds like psilocybin are showing a lot of potential and, if the organisations working on those compounds will avoid the mistakes of past missteps, they will be more methodical,” Olson said in an email. 
 
He also said that there is the newer generations of substances which he referred to as neuroplastogens stating that they have been developed to have the same healing capacity as MDMA but with less impact vices like hallucinations. 
 
“Taken together, it is quite clear that the future is very bright for this class of therapeutics,” he said. 
 
Another expert, Dr. Brian Barnett, is a psychiatrist heading psychedelic research at the Cleveland Clinic, Ohio, also opined that he believes MDMA will ultimately be approved for PTSD treatment despite the FDA’s move. 
 
“I think it will be another arrow in the quiver of psychiatry,” Barnett said. “Yes we do have good treatments for PTSD. They do not work in every instance. 
 
He responded to FDA and the advisory committee’s concerns but pointed out that some of the things they raised about the trials are not special to MDMA. 
 
“The advisory committee was very much preaching and practicing something referred to as functional blinding, wherein the participants would know whether they received the MDMA or the placebo,” he said. The fact is that they were so obsessed with painlessness which, to my utmost astonishment, is an issue for virtually any pharmacological intervention in psychology, at least for functional blinding. 
 
Pressure on the FDA 
 
More than 700 veterans signed a letter in July to the US president Joe Biden where they said they hoped to get federal approval for MDMA for PTSD and that it would be “ amongst the most invaluable PTSD treatments developed for the combating of veteran suicide epidemic. ” 
 
Politicians also weighed in. Congressional letter will now be sent to the President Joe Biden and The Food and Drug Administration commissioner Dr. Robert M. Califf where the authors of the letters stated that “ we cannot allow our veterans to continue to suffer in silence. ” 
 
Lynch of University of Pennsylvania averred that she had personally been shocked to see politicians pressure FDA on the matter which may trigger untimely approvals for psychedelics. 
 
While the agency’s decisions cannot just be based on the science and while questions on safety and efficacy do entail some “judgment” calls, “when politicians step in to support specific products, it can backfire,” she stated. 
 
This critique was not lost on the Institute for Clinical and Economic Review, a nonprofit organisation that seeks to assess the cost and efficacy of therapies, which expressed its disapproval of the progression of the treatment in a report issued in late March of 2021, claiming that patients and providers in the trial tackled psychedelics “more like a cult than like drugs. ” 
 
In a statement after the FDA approved the ongoing and future cautious research, ICER’s chief medical officer, Dr. David Rind expressed hope that how to enhance the benefits and reduce the risks of adding MDMA to these and other psychotherapists would be looked at carefully.