American experts refuse to license a drug based on the drug Ecstasy

Written By Mark

An American advisory committee including experts decided – yesterday, Tuesday – to refuse to license in the United States a drug for post-traumatic stress disorder based on MDMA, a drug also known as Ecstasy, which is consumed illegally during parties.

Lykos Therapeutics is responsible for producing this drug, which is given to patients in parallel with psychotherapy sessions. Clinical trials were conducted on it, but experts concluded that the procedures used to conduct these experiments were insufficient and the strength of the results was not clear.

The Food and Drug Administration (FDA) invited this committee of independent experts to convene to seek its opinion on these data. Although the Commission is not bound by the findings of this committee, it is rare that it does not take its opinion into consideration.

In the vote held in the afternoon, 9 out of 11 experts believed that the drug had not been proven effective in treating post-traumatic stress disorder, and 10 out of 11 considered that its benefits did not outweigh its risks.

One expert, Paul Holtzheimer of the National Center for PTSD, said, “I think it’s an exciting drug, and I acknowledge that we need new and better drugs for PTSD,” but he believed it was “too early to say whether it’s effective or effective.” Safety of its use.

Post-traumatic stress occurs after a traumatic event, and about 5% of Americans suffer from it, for example. Those affected are more at risk of suicidal behavior, drug addiction, and so on. There are currently only two medications approved in the United States, but they are not always effective.

Rapid improvement

About 200 people participated in two similar clinical trials in which half of the participants received MDMA-based medication (or medomafetamine) and the other half received a placebo during 3 sessions of 8 hours each, weeks apart, and were conducted in the presence of a psychotherapist.

Lycos Therapeutics Scientific Director Bera Yazar Klosinski said that the experiment was conducted in a “comfortable room with a sofa” and “soft lighting.”

The doses were separated by a number of psychotherapy sessions.

The FDA noted that participants who received MDMA appeared to have rapid, clinically significant, and sustained improvement in their post-traumatic stress symptoms. But the authority considered that “factors make it difficult to interpret this data.”

On the one hand, due to the strong effects of MDMA on mood and sensation, patients were largely able to distinguish between whether they received the actual drug or a placebo, a factor that may have influenced the results.

On the other hand, the FDA criticized what it described as an “incomplete” assessment of potential side effects, especially with regard to the drug’s risks to the heart. A significant increase in blood pressure and pulse rate was observed among the participants.

The committee’s experts also pointed out that a high percentage of patients included in the clinical trial had previously taken MDMA in the past, and warned that this may have distorted the trial results.


Those included in the trial were also affected by what was included in a recent report issued by the Institute for Clinical and Economic Review (ICER), which reviews clinical trials, which stated that participants in these trials are encouraged to report the benefits of the drug, not its side effects.

FDA official Tiffany Farchione said – in response to a question in this regard on Tuesday – that “investigations” are underway. “We take these allegations very seriously, and they worry us a little,” she added.

Lycos Therapeutics expected in a statement that the Food and Drug Administration would take a decision before mid-August regarding whether or not to license the use of the drug.

If the Authority approves this drug, it is expected to regulate its use in a strict manner, and to limit it to some approved institutions, provided that patients are included in records that allow monitoring of their condition.

It is also a condition that two people supervise the sessions, and patients can only return home accompanied by another adult, and they are not allowed to drive their cars the next day.

MDMA is currently a legally prohibited substance in the United States, and licensing its use for medical treatment purposes would represent a major change.

Scientists are looking increasingly seriously at the possibility of using narcotic substances in general to treat various diseases and psychological disorders, including, for example, depression.

8 important facts about PTSD

Post-traumatic stress disorder

PTSD affects some people who have gone through a traumatic, frightening or dangerous event or experience, according to the National Institute of Mental Health in the United States.

Although people usually suffer from reactions after being exposed to a certain psychological trauma, the majority recover, but in the case of people with post-traumatic stress disorder, the symptoms persist and may worsen.

According to the World Health Organization, traumatic events and bereavement are common in people’s lives.

A study conducted by the organization in 21 countries showed that more than 10% of respondents reported that they had witnessed violence (21.8%), been exposed to cases of violence between individuals (18.8%), experienced incidents (17.7%), suffered the ravages of war (16.2%), or were shocked. Due to the loss of a loved one (12.5%).

The study showed that estimates indicate that 3.6% of the world’s population suffered from post-traumatic stress disorder in 2012.

PTSD often occurs with other psychological problems such as depression, and according to Dr Mark van Ommeren, a scientific researcher from the WHO Department of Mental Health and Addictions, PTSD needs to be managed alongside other common psychological disorders.

Not everyone who goes through a difficult or terrifying circumstance will suffer from PTSD, but everyone who suffers from PTSD has experienced a difficult and harsh circumstance.

Symptoms may begin early after the trauma, within a period of 3 months, and may be delayed for more than a year. Symptoms may last for more than a month and affect the person’s life.

Examples of PTSD triggering events include:

  • Death of someone close.
  • Being raped.
  • Exposure to violence.
  • Wars and natural disasters.
  • Divorce.

It is a symptom of post-traumatic stress disorder

  • Flashbacks: The terrifying event, accompanied by physical symptoms such as heart palpitations.
  • Nightmares.
  • Scary thoughts.
  • Rapid irritability.
  • Stress.
  • Sleep problems.
  • Outbursts of anger.
  • Negative thoughts that run through a person’s mind about themselves or the world.
  • Feelings such as guilt or blame.
  • Loss of interest in enjoyable activities.
  • depression.