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An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.
An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using an illegal drug commonly known as Ecstasy.
Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. Many questions focused on the fact that study participants were by and large able to correctly guess whether they had been given MDMA, also known by the names of Ecstasy or molly.
The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks.
Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.
Many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being.
“I absolutely agree that we need new and better treatments for PTSD,” said Paul Holtzheimer, deputy director for research at the National Center for PTSD, a panelist who voted no on the question of whether the benefits of MDMA-therapy outweigh the risks.