PTBS: No MDMA for America

The Wirkstoff Midomafetamine, which contains more Phase III studies, has some properties with MDMA on. The FDA-approved drugs that have been approved by the FDA and can no longer use, can apply on the basis of the previous date. If Lykos has done a new Phase III study, the certainty and analysis of midomafetamine is one of the problems that arise. In the Hersteller factory, a meeting with the FDA beans, the separation of the überprüfen and the Recfehlungen for a new Einreichung of the Zulassungsantrags treatments is carried out.

FDA-Absage is a schwerer backstroke

“The treatment of the first clinical trials with the treatment of the disease and the treatment of a midomafetamine-supported therapy in patients with moderate PTBS is an enormously complex problem,” explains Dr. Jennifer Mitchell, Professor of Neurology, Psychiatry and Behavioral Sciences at the University of California in San Francisco. Over the years, the study of the sponsors of Lykos was able to continue and continue Phase III studies, which is why Mitchells took the trouble to support the study of midomafetamine. “We have been accepted by the FDA and with a vereinbarten special protocol evaluation. The separation of the FDA, a further Phase III study, is a research for the field of the field.”

This investigation is with Amy Emerson, CEO of Lykos. The FDA investigation, which focuses on large studies, is ongoing in the investigation, and the way the investigation is conducted has been modified. Frustratingly, when you die, “for all the millions of Americans with PTSD and their anxiety, their new experiences are becoming more and more frequent.”

Obschoning de Durchführung einer weiteren Phase-III-Studie more Year dauern würde, “sind wir der Meinung, dass vale der Forderungen, which were treated with the FDA and brought into the Sitzung des Beratungsausschusses voirden, with available Daten, Anforderungen after the Zulassung ofder durch “We hope that the knowledge of literature could be improved,” says Emerson, Lykos became clear to all possible supervisors, an ingenious and fast way for the patient who will use midomafetamin-stimulated therapy for PTBS brauchen.

First new therapy in 24 years

MDMA is used by the methylenedioxyamphetamine family. It is used to experiment with its physical processing. In 2023, the Substanz would begin in Australia to treat PTBS zugelassen. MDMA-AT, a combination of MDMA and psychotherapy, is the first of the psychedelic bases used for therapeutic therapy, which can be used for a study by the FDA in the US. It has turned out to be the first new PTBS medication in 24 years.

MDMA-AT is an initiative of the common useful Multidisciplinary Association for Psychedelic Studies (MAPS). In 2014, MAPS founded the common useful Tochtergesellschaft MAPS PBC. This will disappear from MAPS in 2024 and works with Lykos. In 2017, the FDA MDMA-AT accelerated treatment and Fast-Track status is available.

“Apotheke in der Krise: Handel oder Heilberuf?!” – this theme will take place at VISION.A 2024 in Mittelpunkt. The Zukunftskonferenz für Pharma and Apotheke, made possible by APOTHEKE ADHOC, ARZ Haan AG, PTA IN LOVE and APOTHEKENTOUR present the Antworten on September 10 in Berlin. Here is the program.