Illegal substance used to treat post-traumatic stress

O.D.
English Section / 6 iunie 2024

Illegal substance used to treat post-traumatic stress

Versiunea în limba română

Drugs are being tested more and more often by specialists for treatment schemes in certain conditions. An advisory committee within the US Food and Drug Administration (FDA) is examining the possibility of future authorization of a treatment using MDMA, a drug also known as ecstasy, for post-traumatic stress syndrome (PTSD). The treatment, administered in combination with psychological therapy sessions, was developed by Lykos Therapeutics and was tested in clinical trials. The FDA has convened a committee of independent experts to review the data and that committee will vote at the end of the day to recommend or not recommend the treatment. However, the FDA is not bound by this committee's opinion. Post-traumatic stress syndrome is a psychiatric disorder that occurs after a traumatic event and affects approximately 5% of the American population. There are currently only two treatments licensed in the United States, but they are not always effective. However, the people in question are more prone to suicidal behavior and drug addiction, among others. Almost 200 people participated in two similar clinical trials: half of the participants received MDMA (or midoamphetamine), and the other half a placebo, in three sessions of eight hours each, spaced several weeks apart and carried out in the presence of a Therapist. The sessions took place in a room "comfortable with a couch" and "softly lit," said Berra Yazar-Klosinski, scientific coordinator at Lykos Therapeutics. Several sessions of psychological therapy were then scheduled between each administration. Based on the data collected, participants who received MDMA "appeared to experience rapid, clinically significant, and lasting improvement in their posttraumatic stress symptoms," the FDA reported in a document outlining the meeting's findings. . "However, several factors make these data difficult to interpret," the American agency added. First, because of MDMA's powerful effects on mood and sensation, patients were mostly able to guess whether they were getting the treatment or a placebo, something that could have influenced the results. Moreover, the FDA criticized an evaluation that would be, in its opinion, "incomplete" regarding the possible side effects, especially those aimed at the cardiac risks of the treatment. MDMA is currently an illegal substance in the United States, and therefore its authorization for medical treatment would represent a major change.

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