FDA expands investigation into ecstasy-based drug trials

FDA investigators this week questioned four people about clinical trials sponsored by the company Lykos Therapeutics, people familiar with the matter said. Investigators asked whether side effects were not reported.

The Wall Street Journal reported that Lykos trials missed serious side effects in subjects, including suicidal thoughts.

Lykos did not immediately respond to requests for comment.

The FDA said it could not comment on ongoing investigations.

The agency had said it was reviewing allegations of misconduct in legal proceedings and would incorporate the findings into its decision on Lykos' ecstasy-based therapy. Earlier this month, the FDA rejected the use of the therapy in combination with other therapies to treat people with post-traumatic stress disorder (PTSD).

The FDA's investigation does not end with the rejection, however. This week, officials in the Office of Regulatory Affairs, which oversees the inspections, spoke with at least four people with knowledge of the trials, people familiar with the matter say.

At a meeting in Baltimore, a person treated by Lykos therapists discussed with FDA investigators issues such as overlooked side effects and the therapy techniques used in clinical trials, said Neşe Devenot, a lecturer in the writing program at Johns Hopkins University and a board member of Psymposia, a nonprofit organization critical of Lykos.

Devenot and another person with knowledge of the clinical trials also attended the meeting and spoke with FDA investigators.

Another person familiar with Lykos' clinical trials was also interviewed by FDA investigators in North Carolina this week. The person was interviewed by officials with the Biomedical Research Monitoring Program, a subdivision of the ORA that is supposed to ensure the quality and integrity of data submitted to the FDA. The person shared information about the conduct of the trials, including a study participant's suicidality that went unreported.

The FDA's rejection of Lykos' drug midomafetamine (also known as MDMA or ecstasy) was a blow to long-standing efforts to decriminalize psychedelic drugs and to PTSD patients seeking more effective treatment options.

“The data included in the application have significant limitations 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 the company to conduct a new clinical trial for approval. Lykos now wants to ask the agency to reconsider its decision.

A day after the rejection, the scientific journal Psychopharmacology retracted three articles related to Lykos' early clinical trials of the ecstasy-based therapy. The journal's editors said they had learned of “protocol violations amounting to unethical behavior” on the part of the researchers.

Lykos announced it would lay off 75 percent of its workforce while attempting to resubmit its drug therapy application. Lykos also said Rick Doblin, a longtime psychedelics advocate and founder of the nonprofit organization that created Lykos, has left the company's board of directors.

Write to Liz Essley Whyte at [email protected]