An independent advisory panel to the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting unprecedented regulatory challenges for with a new therapy using an illegal drug commonly known as Ecstasy.
Before the vote, panel members raised concerns about the design of two studies submitted by the drug’s sponsor, Lykos Therapeutics. Many of the questions focused on the fact that study participants were generally able to guess accurately whether they had been given MDMA, also known as Ecstasy or molly.
The panel voted 9-2 on whether the MDMA-assisted treatment is effective and voted 10-1 on whether the benefits of the proposed treatment outweigh its risks or not.
Other panelists expressed concerns about the drug’s potential cardiovascular effects and the possibility of bias among therapists and coordinators who led the sessions and may have positively influence patient outcomes. A case of misconduct involving patients and therapists in the study also weighed heavily on the minds of some panelists.
Many committee members said they were particularly concerned about Lykos’ failure to collect detailed data from participants about the potential for abuse of a drug that produces feelings of happiness and well-being.
“I completely agree,” said Paul Holtzheimer, deputy director of research at the National PTSD Center, a panelist who voted no on the question of whether the benefits of MDMA therapy outweigh the risks. that we need new and better treatments for PTSD.”
“However, I also note that premature adoption of a treatment can actually stunt development, hinder implementation, and lead to premature adoption of treatments that are not completely known. is safe, not completely effective, or not used with optimal effectiveness.” he added.
Although the vote is not binding on the FDA, the agency typically follows the advisory panel’s recommendations. The agency’s final decision is expected to be made by mid-August.
MDMA, or methylenedioxymethamphetamine, sometimes also known as midomafetamine, is a synthetic psychostimulant drug that promotes self-awareness, feelings of empathy, and social connection.
Illegal drugs are listed as Schedule I substances, which are defined as having no accepted medical use and a high potential for abuse. If it wins FDA approval, federal health agencies and Justice Department officials would have to follow certain steps to downgrade the drug’s listing, as is the process today. is underway with cannabis.
The DEA can also set production quotas for drug ingredients, as it does for stimulant drugs used to treat ADHD.
With the panel’s focus on topics such as “euphoria,” “suicidal ideation” and “expectancy tendencies,” Tuesday’s all-day session demonstrated the nuances and complexities that regulators face as they grapple with the unknown territory of a therapy that has only recently entered mainstream psychiatry. following the country’s decades-long war on drugs.
Another tricky thing: The FDA is the drug regulator. It does not regulate psychotherapy and has not evaluated medications for effectiveness tied to talk therapy.
If approved, MDMA-assisted therapy would be the first new treatment for PTSD in nearly 25 years. The disease, which affects about 13 million Americans, has been linked to excessive suicide rates among military veterans, whose suffering has galvanized and urged lawmakers of both parties to commit suicide. prompted a major shift in public attitudes toward therapies based on hallucinogenic compounds.
According to studies submitted by Lykos, patients who used MDMA plus psychotherapy reported significant improvements in their mental health. best Recent drug testing found that more than 86% of those who took MDMA experienced a reduction in the severity of their PTSD symptoms.
About 71 percent of participants improved to the point that they no longer met the diagnostic criteria. According to the data submitted, of those who received the placebo, 69% improved and nearly 48% no longer qualified for a diagnosis of PTSD.
The questions, concerns and apparent skepticism raised by the 10-member panel echoed those raised by agency staff, who last week issued a report. summary document aims to help the panel evaluate the effectiveness and potential adverse health effects of MDMA therapy.
In her opening remarks, Dr. Tiffany Farchione, director of the FDA’s division of psychiatry, noted the regulatory challenges posed by MDMA, saying that “we have learned as we go.” ”. But in her testimony and in staff documents, she and other agency officials repeatedly noted that the overall study results were significant and lasting.
“While this application presents some complex assessment issues, it includes two positive studies in which participants in the midomafetamine group experienced statistically significant and significant improvement,” she said. clinical significance of their PTSD symptoms.” “And that improvement appears to last for at least several months after the end of the acute treatment period.”
Much of the criticism of Lykos’s study design has focused on so-called functional blurring, a problem that affects many studies involving psychoactive compounds. Although the approximately 400 patients participating in the study were blinded to whether they had received MDMA or a placebo, to reduce the incidence of bias in the results, the vast majority were acutely aware of any altered state of mind. , leading them to accurate results. Guess which research group they signed up for.
The FDA, which worked with Lykos to design the trials, acknowledged shortcomings in the study design and recently issued new guidance to address the issues facing psychedelic researchers. face to face.
A number of other critical voices have emerged in recent months. These include the Institute for Clinical and Economic Review, a nonprofit organization that examines drug costs and effectiveness. issued a report called the treatment’s effects “inconclusive” and questioned the results of Lykos’ study.
Other organizations, such as the American Psychiatric Association, do not oppose approval outright, but have called on the FDA to minimize any potential negative consequences by establishing strict, controlled prescription regulations. and strict rationing and close patient monitoring.
FDA staff analysis recommends that approval be contingent on restricted health care facilities, patient monitoring, and diligent reporting of adverse events.
Just before they voted on Tuesday, the advisory panel heard from more than 30 speakers who offered radically different perspectives on the application.
Some critics focus on Rick Doblin, a veteran psychedelic advocate who founded the multidisciplinary Association for Psychedelic Research in 1986, the nonprofit organization that filed the initial application for the drug. MDMA support measures with F.DA. The organization then formed a for-profit entity earlier this year called Lykos.
Brian Pace, a lecturer at Ohio State University, described the company applying for approval as a “therapeutic cult” and criticized Mr. Doblin’s public comments highlighting his enthusiasm for virtual medicine sense, including the belief that their legalization and regulation would bring world peace.
But most of the app’s supporters have offered deeply personal accounts of how MDMA therapy has largely alleviated their PTSD symptoms.
Among them is Cristina Pearse, who said she suffered from PTSD after being sexually assaulted when she was 9 years old. Over the years, she said she was prescribed multiple psychiatric medications and at one point she attempted suicide.
MDMA therapy changed her life, she said. “What once felt like a tsunami of panic was now merely a puddle at my feet,” said Ms. Pearse, who started. an organization Helps women recover from trauma.
She concluded her testimony by urging the FDA to approve the application.
“How many more people need to die before we approve an effective therapy?” she asked. “As you weigh the risks, please remember that this therapy can save lives. I lost most of my life because of this disease. I’m grateful to reclaim it now. But I wish this was a drug approved decades ago.”
