FDA widens probe of Ecstasy-based drug studies
Summary
The Food and Drug Administration is ramping up its investigation of clinical trials that tested an Ecstasy-based therapy, after the agency earlier rejected the application for its approval.
The Food and Drug Administration is ramping up its investigation of the clinical trials that tested an Ecstasy-based therapy, after the agency earlier rejected the application for its approval.
FDA investigators this week interviewed four people about the clinical trials sponsored by company Lykos Therapeutics, people familiar with the matter said. Investigators asked about whether side effects went unreported.
The Wall Street Journal has reported that the Lykos studies missed serious side effects in study subjects, including suicidal thoughts.
Lykos didn’t immediately respond to requests for comment.
The FDA said it couldn’t discuss ongoing investigations.
The agency had said it was looking into allegations of trial misconduct and would incorporate findings into its decision on Lykos’s Ecstasy-based therapy. Earlier this month, the FDA rejected the therapy’s use, combined with therapy, to help people suffering from post-traumatic stress disorder, or PTSD.
The rejection hasn’t ended the FDA’s probe. This week, members of the agency’s Office of Regulatory Affairs, which oversees inspections, spoke with at least four people with knowledge of the trials, according to the people familiar with the matter.
At a meeting in Baltimore, a person treated by Lykos therapists discussed with the FDA investigators subjects including missed adverse events and the therapy techniques used in the clinical trials, said Neşe Devenot, a Johns Hopkins University senior lecturer in the university’s writing program and a board member of Psymposia, a nonprofit critical of Lykos.
Devenot and another person with knowledge of the clinical trials also went to the meeting and spoke to FDA investigators.
Another person familiar with the Lykos clinical trials was also interviewed by FDA investigators this week in North Carolina. The person was interviewed by officials from the Biomedical Research Monitoring Program, a subdivision of ORA that seeks to ensure the quality and integrity of data submitted to FDA. The person shared information on the conduct of the trials, including the suicidality of a study subject that didn’t get reported.
The FDA’s rejection of Lykos’s drug midomafetamine, also known as MDMA or Ecstasy, was a blow to long-running efforts to decriminalize psychedelic drugs and to PTSD patients looking for more effective treatments.
“There are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication," an FDA spokeswoman said after the drug was rejected.
Lykos said the agency had asked it to complete a new clinical trial in order to get approval and that it planned to ask the agency to reconsider its decision.
The day after the rejection, the scientific journal Psychopharmacology retracted three papers related to early Lykos clinical trials of the Ecstasy-based therapy, saying the journal editors learned of “protocol violations amounting to unethical conduct" by the researchers.
Lykos said it would cut 75% of its staff but that it would try to resubmit its application for the drug therapy. Lykos also said Rick Doblin, a longtime psychedelics advocate and founder of the nonprofit that created Lykos, had left the company’s board.
Write to Liz Essley Whyte at liz.whyte@wsj.com
