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Researchers Still Fighting For MDMA Therapy After FDA Advisors Vote Against It
An anonymous reader quotes a report from the BBC: A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs. Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years. A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticized the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August. While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions. Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials. It's an outcome that is "almost double that of existing medications", says Gul Dolen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months." About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd," says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better." "Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection. The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
An anonymous reader quotes a report from the BBC: A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs. Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years. A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticized the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August. While MDMA, also commonly known as ecstasy or molly, is listed as a Schedule 1 controlled substance in the US and so is illegal to use outside research, there has been a growing number of studies suggesting that when used with psychotherapy it could have potential for treating PTSD and some other mental health conditions. Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials. It's an outcome that is "almost double that of existing medications", says Gul Dolen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months." About half of people who enroll in current gold standard PTSD treatments drop out, which is "absurd," says Loree Sutton, a psychiatrist and retired Brigadier General in the US Army. She says new treatments are essential. "We have to do better." "Even if there are risks, we've got to figure this out, because we cannot not let this treatment be available," adds Rachel Yehuda, a professor of psychiatry and neuroscience at the Icahn School of Medicine at Mount Sinai who has conducted studies on the effects of MDMA-assisted therapy for PTSD. "Without it, we're just leaving too many people in suffering that they don't need to be in, and that is not right." The FDA is currently considering an application from California-based drug company Lykos Therapeutics for using MDMA capsules taken in conjunction with therapy in the treatment of PTSD. In the recent FDA advisory meeting, committee members cited apparent flaws in study design and data collection. The nine-hour hearing concluded with committee members voting 9-2 that the available data do not show "that the drug is effective" for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
Read more of this story at Slashdot.
