Three participants in trials for an experimental MDMA therapy told The Wall Street Journal their thoughts of suicide worsened during and after taking the medicine. The potential side effect was not recorded, they said.
The FDA is currently evaluating whether to approve MDMA, commonly known as ecstasy, as a post-traumatic stress disorder medication. If the agency approves the drug candidate, it would be the nation's first new PTSD treatment in 25 years — and the FDA is slated to soon make a decision.
Study subjects said they felt pressured to report positive outcomes and the research focused on symptoms related to one traumatic experience, rather than all trauma and related suicidal thoughts. The participants added they were aware of receiving the MDMA capsules, which introduced a potential bias, according to a WSJ Aug. 5 report.
They also alleged that some of the therapists conducting the trials were involved in illicit therapeutic ecstasy sessions.
FDA employees and the Institute for Clinical and Economic Review have questioned the safety and efficacy of the trials.
The drug's sponsor, Lykos Therapeutics, told WSJ that issues reported from a small number of study participants should not undermine the overall results. Lykos also said it is not aware of any researchers illegally distributing MDMA.
"We really feel that they are sound," Lykos CEO Amy Emerson told WSJ. "The data is reliable."
On Aug. 1, Lykos said it would incorporate additional oversight for the medication if it is approved. Proposed measures include establishing an independent advisory board and collaborating with behavioral health facilities.
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