Even though MDMA, commonly referred to as ecstasy or molly, was approved for the treatment of post-traumatic stress disorder (PTSD) in Australia and was also given by a country’s charity at no cost to support the clinical trial, it failed to receive The U.S. Food and Drug Administration (FDA) approval due to sparse clinical data and allegations of sexual misconduct during trials.

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Insufficient Data

The drug authority was examining the use of psychedelic drugs developed by Lykos Therapeutics to treat mental health disorders in combination with talk therapy. The FDA said it could not determine whether the “drug is safe and effective for the proposed indication” because of insufficient data. The drug agency, in a statement to BBC, said:

“In order to approve a drug, we must determine that the research and data submitted by the sponsor show that the drug is safe and effective for the intended use.”

In response to the rejection, the drugmaker said the agency declined its request to approve the medication based on concerns about limited clinical data and whether psychotherapy adds to treatment benefits and if it’s necessary at all. The company said the agency asked for further study.

While inarguably an important decision, this move by the FDA has also been met with a good deal of disappointment by psychedelics researchers and their advocates — like veterans groups, which have fiercely lobbied for approval. But the broader effort to bring psychedelic drugs into the clinic will continue.

Apart from insufficient trial data, there were also allegations of sexual misconduct during the phase 2 trial. A shocking video posted online shows a therapist involved in the trials telling a participant to spread her legs before pinning her down and lying beside her.

A Canadian patient who had volunteered in one of these pioneer studies carried out in 2015 is now claiming a case of sexual assault against an investigator. The participant said she was a “sex slave” and described the experience as “traumatic;” she has sought legal redress.

Following this, three studies by the same group of researchers were removed from the medical journal Psychopharmacology for misconduct, with the exact nature of the allegations not disclosed.

Potential Benefits

The study aimed to test out the potential application of MDMA to help treat PTSD, with the assumption that using the drug’s pharmacologic action to build up a state characterised by increased trust and minimised fear would create an ideal context for patients working through traumatic memories with a therapist.

Despite this setback, proponents of MDMA-assisted therapy are hopeful that it may be the key to hope for millions of sufferers with PTSD, and even more so for veterans at very high risk of suicide. This technique is believed to help patients be more effective in dealing with these memories of trauma than with just conventional therapies.