FDA gives MDMA therapy for PTSD a setback

(NewsNation) — A committee of outside advisers for the Food and Drug Administration rejected the use of MDMA therapy for post-traumatic stress disorder, a setback for those hoping to increase access to the treatment,

The FDA is not bound by the committee’s decision but often follows its recommendations. The agency could also require the drug’s manufacturer, Lykose Therapeutics, to conduct more studies before resubmitting the drug for approval.

The FDA is expected to decide on approval for MDMA in an Aug. 11 meeting.

MDMA therapy

Formally called midomafetamine, MDMA is also known by the street names “ecstasy” and “molly.” As the name ecstasy might suggest, the drug is known to induce feelings of euphoria.

Panel participants raised concerns about the studies submitted, including the fact that most participants were able to correctly guess whether they had received MDMA or a placebo.

Panelists also questioned bias from therapists and patients and expressed worries about cardiovascular side effects from the drug. There were also questions about how long the drug’s effects would last, though research has suggested the effects from one series of sessions could last for months. Other medications used for PTSD, like SSRIs, typically have to be taken daily.

Approval for MDMA also faces another challenge, which is that while the FDA regulates drugs, it does not typically regulate drugs that are paired with talk therapy.

To treat PTSD, therapists used MDMA with patients during a number of sessions. Prior to using MDMA, patients also had several therapy sessions to prepare, and the treatment was followed by an additional series of appointments to process the experience.

Psychedelic therapy

MDMA is just one of several drugs better known for recreational use that are being investigated for the treatment of mental health disorders, including PTSD and depression.

In many cases, clinical studies have shown positive results, but there are still questions about side effects and the potential for abusing the drugs in a field of therapy that is still experimental.

There are cultural concerns as well. While some drugs used in these approaches, like MDMA and ketamine, are artificial, other plant-based hallucinogens have long roots in indigenous cultures and shamanic healing.

As substances like iboga, peyote, ayahuasca and psilocybin mushrooms have increased in popularity, Indigenous groups have raised concerns about overharvesting and a profit-driven system that could make access to these traditional medications more difficult.

There have also been accusations of cultural appropriation. Scientists have often failed to give credit to Indigenous communities that have worked with these substances for generations and have removed the plants from the traditional spiritual practices that have surrounded them. Outsiders have also often been the ones to profit from commercialization rather than the communities where these therapies originated.

Patients seeking help

The setback for MDMA could also be a blow to patients seeking help. PTSD, as with many mental illnesses, is difficult to diagnose and treat.

The main options offered are psychotherapy, including techniques like EMDR and talk therapy. Only two medications are approved for PTSD, both SSRIs, which are known to come with a host of difficult side effects.

Novel therapies like MDMA and other psychedelics have offered hope for people who don’t respond to current therapies. In any given year, 5% of the U.S. population will suffer from PTSD. Women are more likely to have PTSD than men, and veterans are more likely to experience PTSD than civilians.

In addition to seeking FDA approval, there is also a movement from scientists to reschedule the drug from its current Schedule 1 classification, which would make it easier to conduct research.