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☆ How the Psychedelics Medicine Bubble Burst - The New York Times
▼ + stars: | 2024-08-23 | by ( Caty Enders | ) www.nytimes.com time to read: +2 min

The drug company Lykos Therapeutics had spent much of this year expecting to vault to meteoric heights. It had sent an application to the Food and Drug Administration seeking approval to use MDMA to treat post-traumatic stress disorder. It was the capstone to months of increasingly loud concerns being voiced over the quality of Lykos’s clinical trials. Lykos has spent years conducting clinical trials testing whether MDMA-assisted psychotherapy could alleviate the symptoms of PTSD. Its most recent drug trial showed that more than 86 percent of people treated had a measurable reduction in symptom severity.

Persons: ”, Lykos Organizations: Lykos Therapeutics, Food and Drug Administration, Lykos, Merck

☆ FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say
▼ + stars: | 2024-08-13 | by ( Deidre Mcphillips | Carma Hassan | ) edition.cnn.com time to read: +11 min

The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD. The advisers said it was also difficult to parse how much the accompanying talk therapy — an area that the FDA does not regulate — contributed to outcomes. Advocates for the treatment, including some veterans groups, said they were “incredibly disappointed” by the FDA decision. Dozens of clinical trials involving psychedelics are in various stages, and additional scrutiny can help strengthen the findings and build confidence. Psychopharmacology did not allow the study authors to publish a correction with data that excluded findings from one study site, said Allison Feduccia, an author in all three retracted studies.

Persons: Lykos, —, ” Martin Steele, Brett Waters, ”, Rachel Yehuda, “, ‘, Michael Bogenschutz, Yehuda, It’s, Lori Bruce, Psychopharmacology, caressed, “ it’s, Amy Emerson, ” Lykos, Allison Feduccia, Dr, Sanjay Gupta, Brian Barnett, ” Bruce, Nadia Kounang Organizations: CNN, Food and Drug Administration, Lykos Therapeutics, FDA, Veteran Mental Health Leadership Coalition, Hope, Center, Psychedelic Psychotherapy, Mount, Icahn, of Medicine, NYU Langone Center, Psychedelic Medicine, Oxford, NUS, Neuroethics, Interdisciplinary Center, Bioethics, Yale University, ”, Multidisciplinary Association for Psychedelic Studies, Health Canada, Institutional, Board, CNN Health, Cleveland Clinic Locations: Canada, “

☆ Three Studies of MDMA Treatment Retracted by Scientific Journal
▼ + stars: | 2024-08-12 | by ( Andrew Jacobs | More About Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place. Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.

Persons: Lykos Organizations: Lykos Therapeutics, Food and Drug Administration

If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos added that the agency expressed concerns similar to those raised during the advisory committee meeting in June. Davis Institute for Psychedelics and Neurotherapeutics, said he doesn’t think the FDA decision will hinder the development of psychedelics for mental health disorders, including PTSD.

Persons: “, ”, Holly Fernandez Lynch, Lykos, Amy Emerson, Sarah Silbiger, David Olson, Olson, ” Olson, Brian Barnett, ” Barnett, Joe Biden, Biden, Robert Califf, ” Lynch, psychedelics, David Rind Organizations: Drug Administration, Therapeutics, FDA, Lykos Therapeutics, University of Pennsylvania, Davis Institute for Psychedelics, Cleveland Clinic, Clinical Locations: U.S, White Oak, Md, Ohio

☆ F.D.A. Declines to Approve MDMA Therapy, Seeking More Study
▼ + stars: | 2024-08-09 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments. An additional clinical trial could add years, and millions of dollars, to the approval process. If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. “This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics.

Persons: F.D.A, ”, Michael Pollan Organizations: Drug Administration, Lykos Therapeutics, UC Berkeley Center, Psychedelics

☆ F.D.A. Panel Rejects MDMA-Aided Therapy for PTSD
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using the drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies submitted by the drug’s sponsor, Lykos Therapeutics. The panel voted 9-2 on whether the MDMA-assisted therapy was effective, and voted 10-1 on whether the proposed treatment’s benefits outweighed its risks. Other panelists expressed concerns over the drug’s potential cardiovascular effects, and possible bias among the therapists and facilitators who guided the sessions and may have positively influenced patient outcomes. A case of misconduct involving a patient and therapist in the study also weighed on some panelists’ minds.

Organizations: Food and Drug Administration, Lykos Therapeutics

☆ F.D.A. Panel Weighs MDMA Therapy and Its Risks
▼ + stars: | 2024-06-04 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks. The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy. Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists.

Persons: Alexander Shulgin Organizations: Drug Administration, Lykos Therapeutics, Merck Locations: Bay

☆ PTSD Treatments Are Falling Short for Many Patients
▼ + stars: | 2024-06-04 | by ( Dani Blum | ) www.nytimes.com time to read: +1 min

They withdraw — often reluctant to talk about what they’ve experienced and unable to trust others or themselves. The treatments for PTSD — including several forms of psychotherapy and medication — are effective for many patients, but they don’t work for everyone. Sometimes, they can be so distressing that patients stop the treatment before it’s complete. On Friday the Food and Drug Administration declined to approve what would have been the first new treatment for PTSD in decades, a therapy that combined the psychoactive drug MDMA with talk therapy. approve the treatment, citing concerns about safety and issues in clinical trials.

Persons: —, it’s Organizations: and Drug Administration, Lykos Therapeutics

☆ F.D.A.’s Review of MDMA Cites Health Risks and Study Flaws
▼ + stars: | 2024-05-31 | by ( Andrew Jacobs | Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo. It also flagged “significant increases” in blood pressure and pulse rates that could “trigger cardiovascular events.”The staff analysis was conducted for an independent advisory panel that will meet Tuesday to consider an application by Lykos Therapeutics for the use of MDMA-assisted therapy. The agency’s concerns highlight the unique and complex issues facing regulators as they weigh the therapeutic value of an illegal drug commonly known as Ecstasy that has long been associated with all-night raves and cuddle puddles. Approval would mark a seismic change in the nation’s tortuous relationship with psychedelic compounds, most of which the Drug Enforcement Administration classifies as illegal substances that have “no currently accepted medical use and a high potential for abuse.”

Persons: ” Organizations: Drug Administration, Lykos Therapeutics, Drug

☆ MDMA therapy could be legalized by summer. Why are so many advocates sounding the alarm?
▼ + stars: | 2024-05-13 | by ( Anna Silman | ) www.businessinsider.com time to read: +52 min

Last summer, thousands of tie-dyed Burners and Patagonia-clad tech founders converged on the MAPS Psychedelic Science conference in Denver. The experience "broke the spell of this trauma, and she was able to rebuild her life," Doblin told The Guardian . The video team's job was to store recordings of every MDMA therapy session performed in the clinical trials. Grof believes in something called an "inner healing intelligence," an innate capacity for self-healing that psychedelic therapy helps unleash. Another time, a patient who had come to an MDMA therapy session later acknowledged they had been under the influence of LSD during treatment.

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