America rejects a drug license to treat "post -trauma disorder"

The US authorities have refused to license the narcotic MDMA medicine produced by Lykos Therapeutics to treat post -traumatic disorder and requested more data, which is a setback for this emerging sector that has obtained supporters from different political spectrums. The US Food and Drug Administration, which, according to Bloomberg, was under pressure from treatments to traumatic disorder, told the medicine manufacturer that there was a need for another wide study before the start of the sale of treatment. This mental health condition, which can develop into painful events that threaten life, affects nearly 13 million Americans. There are not many effective treatment options. The distribution of these medical conditions, especially among the country’s veterans, as well as promising early results, led to a wave of support for MDMA. However, questions soon emerged whether the treatment would be used safely and appropriately, and whether the initial results were reliable. The US Food and Drug Administration said in a statement: “There are major restrictions on the data in the application, which prevents the agency from concluding that this drug is safe and effective.” Request a review and the company refuses to request US drug management and food, saying that it will take a long time to complete the work, and plan to request a meeting with the administration to request a review of the decision. The CEO of Lykos Emerson said in a statement that the request to conduct another study was “very disappointing, pointing out that it would take a few years to complete the experiments requesting the agency. The issues raised by the Food and Drug Administration in the full answer letter it sent to Lykos were the focus of the meeting of the Counseling Committee in June last year. It is widely expected to postpone the administration or to completely reject the request, when the Food and Drug Administration advisors voted against the use of MDMA. They concluded that Lykos did not prove the effectiveness of the drug, saying that patients could know if they received a healing in MDMA instead of an imaginary medicine, and that they may have improved. Advisors were also tortured with limited information on negative events and a possible misconduct in clinical trials. The Multidisciplinary Society for Psychological Studies – The Non -Profit Organization behind Lykos – said in a statement that it “assesses the next step to provide safe and legal access to treatment with MDMA.” ‘Frustrating case’ and the defenders hoped that the treatment would become the first new medicine for the traumatic disorder for more than two decades. “It’s frustrated, it’s a frustrating thing,” said Jessi Gold, a 37 -year -old army soldier who was diagnosed with the post -shocking disorder, who defended MDMA through his Heroic Hearts project project. He added: “The food and drug administration has the luxury time to postpone this matter, but I do not have enough time for it, similar to the vast majority of ancient warriors in this country, in light of the ongoing suicide phenomenon without a solution.”