FDA Rejects Ecstasy-Based Drug
The agency declined to approve the psychedelic drug’s use treating post-traumatic stress disorder
The Food and Drug Administration turned down an ecstasy-based drug.
The agency rejected use of the drug, known as MDMA, along with mental-health therapy in the treatment of post-traumatic stress disorder. It asked Lykos Therapeutics, which had sought the approval, to test the drug therapy further, the company said Friday.
The decision is a setback for decades of efforts to legalize psychedelics and a disappointment for veterans advocates and other groups that have been seeking a new, better medicine for treating the 13 million Americans with post-traumatic stress.
Yet it isn’t a surprise, after FDA staff and expert advisers raised questions about the studies evaluating whether the MDMA drug from Lykos Therapeutics worked safely.
Lykos said the FDA told the company it couldn’t approve the drug therapy based on the data submitted to date. The company said it would ask the FDA to reconsider its decision, as well as to discuss the agency’s recommendations for submitting another application.
“There’s a clear need that’s out there,” said Lykos Chief Executive Amy Emerson. “The need doesn’t go away, and the data that we have doesn’t go away.”
Emerson said Lykos believes it can address the FDA’s concerns with the study data it has already collected and references to scientific literature. She said conducting the late-stage study requested by the FDA would take several years.
Other companies chasing psychedelic drugs that promise to help with debilitating mental-health problems are expected to continue their pursuits.
Investors, who have plowed billions of dollars into the companies, said they have hope for other psychedelic drugs in the works because they are being tested differently than the MDMA drug.
MDMA, or midomafetamine, has been a favorite of clubgoers because it can reduce inhibitions and promote feelings of euphoria.
Its use, outside of specific medical settings authorized by drug regulators, has been illegal. Ecstasy shares the same Drug Enforcement Administration classification as heroin and LSD.
Use of the drug can result in serious side effects, including sharp increases in body temperature that can cause organ failure, brain swelling and, in rare cases, death.
About 13 million Americans, including some veterans and victims of sexual assault, suffer from post-traumatic stress. Few medicines are approved to treat them, and doctors and patients complain they don’t usually work well.
Lykos’s drug had raised hopes for a new, better option. The data Lykos sent the FDA from its two major clinical trials showed the treatment significantly reduced patients’ PTSD symptoms and caused many of them to no longer qualify for their original diagnoses.
Dozens of members of Congress signed a letter earlier this week urging FDA to approve the treatment and highlighting the need for treatment options for veterans.
But company-sponsored studies were marked by problems.
A subject of a middle-stage trial said she was sexually assaulted and abused by the married therapists overseeing her involvement. Her lawsuit against the therapists was settled out of court on undisclosed terms.
Lykos has said what happened was malpractice and that it cut ties with the therapists.
The Wall Street Journal reported that suicidal thoughts worsened in three people during and after testing, but the studies didn’t capture that. They said they felt pressure to report positive results and support a history-making treatment.
Some of the therapists who were conducting the trials also administered ecstasy on the side in “underground” therapy sessions, The Journal reported.
Lykos has said it conducted studies properly, after consulting with the FDA, and the experiences of three people shouldn’t undermine overall positive study results. The company said it wasn’t aware of therapists involved in the trials who were administering ecstasy illicitly at the same time.
In June, experts advising the FDA recommended against approval. The advisers expressed concerns that the data Lykos presented was incomplete or unreliable, pointing out that 40% of patients in the trials had previous experience with MDMA and other unusual elements of the clinical trials.
Industry experts said other companies developing psilocybin, LSD and other psychedelic drugs for mental-health disorders will use the FDA’s rejection as a guide.
“It seems like the issues are Lykos-specific, not something to do with FDA’s broader views of the class of medicine,” said Matthew Baggott, chief executive of Tactogen, a company developing drugs similar to MDMA.
Kabir Nath, CEO of Compass Pathways, said its final-stage testing of psilocybin for treatment-resistant depression takes a different approach than Lykos’s.
For instance, the Compass final-stage studies follow patients for an entire year, rather than the several months that Lykos looked at. Also, Compass will pair its drug with support from a mental-health professional, rather than therapy—a difference that Nath said should make it easier for the FDA to discern the effects of the drug itself.
Rick Doblin, a board member of Lykos and founder of the advocacy organization that created it, has spent roughly four decades advocating for psychedelics. He said before the FDA’s decision that he would remain hopeful about MDMA’s future no matter which course the agency took.
“Whatever FDA says, there will be a pathway towards approval,” he said. “I don’t intend to stop working on this until FDA approval has been obtained.”