FDA Analysis Finds Flaws In MDMA Treatment Study

Committee To Decide If MDMA-Assisted PTSD Treatment Will Move Forward

On Friday, the US Food and Drug Administration (FDA) raised concerns over the quality of the studies submitted for the consideration of MDMA (ecstasy) as a treatment for post-traumatic stress disorder (PTSD).

The studies, which are part of the proposal by Lykos Therapeutics for the use of MDMA-assisted PTSD treatment, were flagged for possible bias as well as the significant health risks documented in the results.

Though a committee is expected to meet on Tuesday to further discuss and hear from the public, field insiders acknowledge that whether approved or denied, this proposal marks a paradigm shift in the field of psychiatry regarding the medicinal use of psychedelics.

How Does MDMA Help Treat PTSD?

MDMA, or 3,4 methylenedioxy-methamphetamine, is both a stimulant and hallucinogen that can produce feelings of euphoria and connectedness. In recent years, there has been growing interest in the claims that MDMA, when used in conjunction with psychotherapy, can cause significant improvement in many psychiatric conditions, including PTSD, depression, anxiety, and substance use disorders.

These claims are mostly attributed to how MDMA affects the brain by increasing the levels of oxytocin, dopamine, and serotonin, making a person feel happier, more self-aware, and more empathetic. It also helps regulate areas in the brain involved in fear and anxiety, two prominent symptoms of PTSD.

Advocates Highlight Urgent Need For New PTSD Treatment

While initial claims sound promising, current research on MDMA-assisted therapy is lacking. However, the most recent drug trial submitted by Lykos Therapeutics found that 86% of participants who received MDMA treatment reported a reduction in the severity of symptoms, with 71% of those reporting such drastic improvement that they no longer met PTSD diagnosing criteria. Results like this give advocates hope that the approval of this treatment could greatly help people who struggle with PTSD improve their quality of life.

The National Institute of Mental Health reports that 3.6% (over 10 million people) of the US population had PTSD in the past year. Veterans represent a disproportionate amount of these diagnoses, with 7 out of 100 veterans meeting the diagnostic criteria for the disorder. This is particularly concerning, as a PTSD diagnosis significantly increases a person’s risk for suicidal thoughts and actions. Add that to the fact that there have been no new approved treatment medications for PTSD in the last 20 years, and you’ll better understand how desperate proponents are for something new.

FDA Concern Focused On Heart Health And Study Bias

Various groups and lawmakers from both parties have rallied in support for the use of MDMA therapy for PTSD, but the FDA’s analysis might put their plans on hold. In the analysis, the FDA highlighted concerns regarding the effects of MDMA on the cardiovascular system. MDMA can cause increased heart rate and raised blood pressure, which can be particularly dangerous for those with preexisting heart conditions.

Other cardiovascular risks increased by MDMA use include:

• Heart attack
• Myocardial necrosis
• Arrhythmia
• Valvular heart disease
• Dilated cardiomyopathy

Further clouding the conversation is the accusation of study bias made by the FDA and other outside sources. Earlier this year, the Institute for Clinical and Economic Review released a 108-page report criticizing Lykos’ study results. The independent nonprofit, which assesses the cost and effectiveness of medications, claimed that study participants admitted that they felt pressured to report positive results, fearing retaliation if they said otherwise. They further went on to say that the study sizes were often small and possibly biased, as 40% of participants claimed to have previous experience taking MDMA.

Lykos Therapeutics CEO Amy Emerson countered by saying that the studies were developed in consultation with the FDA and that studies of psychoactive medications are complicated to begin with, as participants are acutely aware of MDMA’s effects. She further went on to say that ultimately rejecting the proposal will cause PTSD patients to seek out unregulated treatments, possibly causing greater harm.

What Happens Next?

An independent advisory panel will meet on Tuesday to discuss the proposal and the FDA staff analysis. There will also be a 2-hour time slot for public comments. The agency is then expected to announce a decision by mid-August.

If the proposal is approved, it still has a long road ahead of it before MDMA would easily be placed in the hands of patients. The Justice Department and other federal health authorities would start the lengthy process of downgrading MDMA from a Schedule I controlled substance, which is defined as having no current medical use. Then, the FDA would most likely impose strict guidelines for its use, with the staff analysis already proposing setting, monitoring, and tracking requirements.

Treatment providers work with many insurances, including:

Check if my insurance covers rehab

Addiction Center is not affiliated with any insurance.

Find Treatment For PTSD

While MDMA-assisted treatment might be an option in the near future, don’t wait to get help if you are experiencing the effects of PTSD. Therapeutic techniques, like CBT and DBT, can help a person process their painful memories and work towards healing. Online therapy can provide these therapeutic options to you in the comfort of your own home and on your schedule. Explore your online therapy options and get started today.