The agency asked Lykos Therapeutics to “conduct an additional phase 3 trial” to obtain data on the “safety and efficacy” of the treatment, according to the statement released Thursday.
:quality(50)/2023/07/06/64a68815cd1a7_placeholder-36b69ec8.png)
Published
Updated
Reading time: 1 min
:quality(50)/2024/08/10/000-9tg2u9-66b71f9bf0574759858466.jpg)
The U.S. Food and Drug Administration (FDA) has refused to approve a treatment for post-traumatic stress disorder that uses MDMA, a drug known as ecstasy, according to a statement released Thursday, August 8, by the company that develops it, Lykos Therapeutics. The FDA said it cannot approve the treatment “based on data reported to date” and asked the company to “conduct an additional phase 3 trial” to obtain data on “safety and efficiency” of the treatment, according to the press release.
MDMA is an illegal substance in the United States, so its approval for medical treatment would represent a major change. The treatment, which contains ecstasy, better known for its illegal recreational use, has been tested several times and was accompanied by psychotherapy sessions. In June, an advisory committee of American experts, convened by the FDA, which often follows its advice, voted against the treatment, based in part on one of the tests, according to a press release released on June 27.
Just under 200 people took part in two similar clinical trials: half of the participants received MDMA (or midomafetamine) and the other half a placebo, during three eight-hour sessions, spaced several weeks apart and conducted in the presence of a therapist. The participants who received MDMAt “appeared to observe rapid, clinically significant and sustained improvement in their post-traumatic stress symptoms”according to the FDA, but the agency had criticized an assessment “incomplete” possible side effects.
She also noted that because of ecstasy’s powerful mood- and sensation-altering effects, patients were largely able to guess whether they had received the drug or a placebo, which may have influenced the results. Post-traumatic stress disorder occurs after a traumatic event and affects about 5 percent of the U.S. population. Those affected are at increased risk of suicidal behavior and drug addiction, among other things. There are currently only two approved treatments in the United States, and they are not always effective.
