An American agency refuses to approve a drug for post-traumatic stress disorder

An American agency refuses to approve a drug for post-traumatic stress disorder
The US Food and Drug Administration has refused to approve a treatment for post-traumatic stress disorder based on the drug MDMA, known as Ecstasy, according to a statement issued by Lycos Therapeutics, the company that developed it.
The US agency indicated that it could not confirm the treatment’s efficacy “based on the data provided to date,” and asked the company to “conduct an additional third-stage trial” to obtain data on the “safety” and “efficacy” of treatment, according to what was said in the statement.
American laws prohibit the use of MDMA in the United States. Therefore, his consent to medical treatment would have represented a significant change in this context.
Several tests were carried out on the treatment, which includes the substance “Ecstasy”, which is known for its illegal use for recreational purposes, and psychological therapy sessions were included.
In June, an advisory committee made up of American experts, established by the US Food and Drug Administration, which often follows his advice, voted against this treatment based on the results of one of the tests.
Around 200 people took part in two similar clinical trials, in which half of the participants received MDMA (or medomafetamine) and the other half received a placebo, in three eight-hour sessions, with a difference period of several weeks, and present. psychologist.
The findings showed that participants given MDMA “appeared to experience a rapid, clinically significant and lasting improvement in PTSD symptoms,” according to the US Food and Drug Administration, but the agency criticized the “incomplete” assessment of possible side effects.
The group also noted that due to the powerful effects of Ecstasy, which affects emotions and feelings, to a large extent patients were able to tell whether they received the treatment or a placebo, which may have had an effect take the results.
PTSD occurs after a traumatic event, and about 5% of Americans suffer from it.
The people involved are, among other things, more vulnerable to suicidal behavior and drug addiction.
There are currently only two treatments approved in the United States for PTSD, and they are not effective in all cases.