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It May Be a While Before MDMA Receives Government Approval

FDA approval of MDMA Treatment shown by blocks

The notion that there are benefits to MDMA therapy for PTSD isn’t a new concept. The way the drug works can greatly improve a variety of symptoms that occur after a trauma. In fact, the FDA even added MDMA to a list of fast-track medicines that deserve accelerated study. But recent studies are raising some side effect concerns and may have inherent flaws in their design. These could represent major obstacles in gaining FDA approval of MDMA treatment in PTSD and other conditions. While many believe the eventual approval of MDMA will occur, the FDA could impose additional demands before that happens. As a result, MDMA’s future in treating mental health conditions remains unknown.

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Using MDMA Therapy for PTSD

FDA approval of MDA Treatment in a form
FDA approval of MDMA treatment is proving elusive.

When it comes to MDMA or Ecstasy, it does routinely fall into the psychedelic class of drugs. But interestingly, it doesn’t work the same as other hallucinogens like LSD or magic mushrooms. Instead, MDMA works as an empathogen. In other words, it enhances one’s ability to empathize with others and feel what they may be feeling. It also boosts feelings of social connectedness, which is why it has been used recreationally. However, these are the same attributes that may MDMA therapy for MDMA attractive. Avoidance symptoms specifically can be notably improved in this population with MDMA. Likewise, with talk therapy, deeper understandings of traumatic experiences and emotions can be gained. This is why many advocates hope for FDA approval for MDMA treatment in this condition.

The other reason that many want FDA approval for MDMA treatment in PTSD is the lack of effective interventions. It has been roughly two decades since the last therapy for PTSD was approved by the agency. And millions of Americans including veterans suffer from the disorder’s effects. To highlight why new treatments are needed so badly, one only needs to look at PTSD suicide rates. On average, about 20 veterans commit suicide related to PTSD each day in the U.S. according to some reports. Such statistics and early evidence supporting MDMA therapy for PTSD identified it as a potential breakthrough therapy in 2017. Since that time, hope that FDA approval of MDMA treatment will occur has persisted.

Recent Studies of MDMA in PTSD

The most recent study prompting discussions about MDMA therapy for PTSD was performed by the pharmaceutical company, Lykos. In the study, 200 patients with PTSD were enrolled with half receiving MDMA dosing and half placebo. Those receiving MDMA were given 80-120mg initially combined with talk therapy for each session. They then received a second dose that was half as strong two hours later. Overall, each person attended three sessions that lasted eight hours, and these sessions were separated by four weeks. The participants also attended three appointments to prepare them for the treatment and nine sessions thereafter. The latter sessions were to discuss what was learned and experienced overall. In an effort to increases chances of FDA approval of MDMA treatment, Lykos worked with the FDA in the study’s design.

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The results of the study did indeed show significant benefits with MDMA therapy for PTSD. For those receiving MDMA, the study reported that 86% had a significant improvement in symptoms. Likewise, a total of 71% no longer met diagnostic criteria for PTSD afterwards. In contrast, these same percentages were 69% and 48% respectively for the placebo group. Based on this, Lykos presumed they had good chances for FDA approval of MDMA treatment for PTSD. Unfortunately, however, it seems that both participants and researchers knew which group received actual MDMA versus placebo. Notably, it was difficult to be aware of the actual drug’s effects, which made “blinding” the study challenging. In addition, some significant increases in both blood pressure and pulse rates were seen in the treated group. Both of these issues involving MDMA therapy for PTSD could also prevent FDA approval of MDMA treatment.

FDA’s MDMA Decision Forthcoming

a bunch of E pills in a row
MDMA therapy for PTSD might be viable, but the FDA isn’t keen on exploring the idea.

In addition to the FDA’s concerns about MDMA safety and effectiveness, other groups have expressed worries as well. Specifically, the Institute for Clinical and Economic Review noted that the participants in Lykos’ study had a much higher baseline MDMA use than the normal population. They also recognized that the therapists involved were highly in favor of using MDMA therapy for PTSD. Though the Institute is not opposed to MDMA in medicinal use, red flags were noted. As a result, they have suggested caution before moving forward with an FDA approval of MDMA treatment. They believe better and additional studies should be required despite the need for better mental health interventions.

In terms of the FDA, an advisory panel will meet soon to further discuss. And a final decision is expected in August regarding MDMA therapy for PTSD. Given the potential side effects and study design biases, the FDA approval of MDMA treatment is up in the air. It may be that MDMA therapy for PTSD will be approved but with significant restrictions regarding protocols. The APA is actually in favor of this in an effort to make sure trained professionals apply the treatment. But the FDA may also require additional research be performed before granting its approval. In either case, few are now expecting smooth sailing for MDMA use in PTSD.

 

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