Enlarge / President of Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin speaks onstage during the 2023 Concordia Annual Summit at Sheraton New York on September 18, 2023, in New York City. (credit: Getty | John Lamparski)

There's more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month.

According to a report from The Wall Street Journal, the FDA is now expanding an investigation into clinical trials behind the experimental psychedelic therapy—even though the agency has already rejected it. Agency investigators reportedly interviewed four additional people last week, asking questions regarding whether the trials underreported side effects.

People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA's review, with outside experts and agency advisers calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.

Enlarge / MDMA (credit: Getty | PYMCA/Avalon)

A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.

On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisers identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).

FDA advisers also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.

Enlarge / MDMA pills up close. (credit: Getty | Universal History Archive)

After a remarkably sensational regulatory drug review, advisers for the Food and Drug Administration on Tuesday voted overwhelmingly against approving midomafetamine (MDMA, aka ecstasy or molly) as part of therapy for post-traumatic stress disorder.

In a response to the question, "Do the available data show that the drug is effective in patients with posttraumatic stress disorder?" advisers voted 9 "no" to 2 "yes" against MDMA.

The votes come after a full-day meeting in which the independent expert advisers heard detailed reviews of clinical trial data from the company that proposed the therapy—Lykos, formerly MAPS—as well as internal FDA reviews.