Slashdot Mirror
Domain: maps.org
Stories and comments across the archive that link to maps.org.
Stories · 2
-
FDA Designates MDMA As 'Breakthrough Therapy' For PTSD (futurism.com)
In what could lead to a faster path to pharmaceutical approval, the U.S. Food and Drug Administration (FDA) has designated methylenedioxymethamphetamine (MDMA) as a "breakthrough therapy" in the treatment of post-traumatic stress disorder (PTSD). Futurism reports: The Multidisciplinary Association for Psychedelic Studies (MAPS) announced the FDA's ruling last week, revealing that they can now move forward on two of their upcoming "Phase 3" trials. The goal of these trials is to determine how effectively the drug can be used to treat those suffering from PTSD. The trials will include 200 to 300 participants, and the first trial will begin to accept subjects in 2018. The trials will be held in the U.S., Canada, and Israel, and MAPS plans to open talks with the European Medicines Agency in the hopes of expanding testing to include Europe. For now, the focus is on securing the funding they require. According to Science, the organization is still in the process of raising money for the trials, and thus far, they've only managed to secure $13 million, about half of their goal.
Previous MAPS trials exploring how well MDMA could treat PTSD have yielded favorable results, contributing to the FDA's aforementioned decision. In the association's Phase 2 trails, 107 people who had PTSD for an average of 17.8 years were treated using MDMA-assisted psychotherapy. After two months, 61 percent of the participants no longer suffered from PTSD. After a year, that number increased to 68 percent, according to the MAPS press release. -
FDA Approves Large Clinical Trial For Ecstasy As Relief For PTSD Patients (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported. The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy -- or 3,4-Methylenedioxymethamphetamine (MDMA) -- saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available. Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients. The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana. Also like the others, the new, larger trial will involve a limited number of MDMA treatments administered by professional psychotherapists as part of a therapy program. In previous trials, patients spent 12 weeks in a psychotherapy program, including three eight-hour sessions in which they took MDMA and talked through traumatic memories.