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“Hearing I had PTSD — it felt like I didn’t earn it,” said Natalia Chung, 30, who was diagnosed with the disorder in 2016 after ending an abusive relationship. “Because I didn’t go to war,” she said. The second Phase 3, philanthropy-funded, clinical trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) was completed in November 2022. Now, the trial sponsor MAPS published an announcement confirming prior positive results from the first Phase 3 trial. No serious adverse events were observed among the participants. The full data, expected to be published in a peer-reviewed journal later this year, will support a new drug application to be filed with the U.S. Food and Drug Administration (FDA). MDMA has been shown to have dramatic potency in treating PTSD when combined with talking therapy—a finding so significant that it was hailed as one of Science magazine’s ten breakthroughs of 2021, sharing the stage with advances on Covid-19 and nuclear fusion. In 2019, the FDA granted the Breakthrough Therapy Designation for the MAPS study. PTSD affects 8 million Europeans. It is a real medical emergency, an eminently treatable condition, and a blind spot in Europe. Dozens of trials are happening in Europe and all over the world to investigate the potential of psychedelic novel treatments for many other conditions like depression, anxiety, alcohol and nicotine addictions, eating disorders, headaches and more. The full list of ongoing clinical trials alongside indications they address can be browsed here: Mapping Drug Development in Psychedelics. Europe needs to recognize the tremendous opportunities that psychedelic-assisted therapies can offer to patients in need. Likewise, we need to understand and address challenges specific to implementing those novel treatments in to avoid their premature introduction to clinical practice in poorly regulated ways that can risk patients' health and well-being as well as medicine's credibility. To that end, during the event in the European Parliament in December 2022, PAREA launched an appeal to the European policymakers calling on the EU to start preparing for the arrival of those therapies in Europe.
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