Biography/Memoir

MDMA therapy didn’t get FDA approval. Now what?

The FDA declined to approve the new treatment submitted by Lykos Therapeutics, an organization that develops innovations to “transform mental healthcare,” deciding that there still isn’t enough evidence of benefit to outweigh the risks. The decision will have far-reaching ripple effects. Some psychedelic advocates will have to put celebrations they’ve been planning for decades on pause;…

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Biography/Memoir

Lykos… moved to patent MDMA in late 2022, filing reveals

…another big ‘if’ is whether the company will even obtain FDA approval for its MDMA-assisted therapy at all… Specifically, Lykos’ patent application claims a composition comprising a salt or solvate of MDMA along with one or more excipients, where the average particle size in the composition is, at its broadest, between 50 and 400 microns,…

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Biography/Memoir

After FDA setback, psychedelic drugmakers distance themselves from a pioneer

A resoundingly negative vote by an advisory committee to the Food and Drug Administration on Tuesday [6/5/24] – though not binding – has diminished the chances of the sponsor, Lykos Therapeutics, from winning full approval for MDMA to treat post-traumatic stress disorder, industry observers said. But biotech executives, investors and researchers said in interviews that…

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Politics

FDA panel rejects MDMA-assisted therapy for PTSD

An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday [6/4/2024]. While the vote is not binding on the F.D.A., the agency often follows the recommendations of its advisory panels. Members of an independent scientific advisory committee voted 9 to 2 that human…

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Medicine/Healing

The VA’s high hopes for psychedelics

Why the VA matters: It’s the largest health system in the country and serves a population with disproportionately high rates of PTSD. The VA announced in January [2024 that it would fund research into psychedelics like MDMA, also known as ecstasy, and psilocybin as potential treatments for post-traumatic stress disorder and depression. While outside groups have…

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Medicine/Healing

Psychedelic biotech MAPS PBC rebrands to Lykos following FDA filing, scores $100M financing

MAPS PBC [Public Benefit Corporation) has rebranded to Lykos Therapeutics [a for-profit public benefit corporation (“PBC”)], (“Lykos”), the greek word for wolf.  MAPS PBC spun out of its parent organization MAPS (Multidisciplinary Association for Psychedelic Studies)… clinical development effort of MDMA-assisted therapy [midomafetamine capsules used in combination with psychological intervention], which includes talk therapy, and…

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Politics

MAPS PBC announces new American Medical Association CPT III codes for psychedelic-assisted therapies take effect

MAPS PBC [Public Benefit Corporation] and COMPASS Pathways collaborated to work with the AMA [American Medical Association] to create these new CPT III codes.  These are temporary codes assigned to emerging technologies, services and procedures, to facilitate reimbursement and support access to psychedelic therapies in the United States, if such therapies receive regulatory approval by the…

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Biography/Memoir

US Presidential candidate… says legal psychedelic therapy should be paid for with universal healthcare system

Marianne Williamson, a 2024 Democratic presidential candidate, says the federal government should “fully legalize” certain psychedelics like psilocybin for therapeutic use and cover the costs for patients under a universal healthcare system. “In states where psychedelic-assisted psychotherapy has been legalized, it is still so costly that many cannot afford it. We cannot allow cost to impede…

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Medicine/Healing

MDMA therapy inches closer to approval

PTSD affects about 5 percent of the adult population of the United States each year… federal approval for MDMA-assisted therapy would also mean the drug would have to receive a less serious ranking for controlled substances by the D.E.A. and from states. MDMA-assisted therapy seems to be effective in reducing symptoms of post-traumatic stress disorder, according…

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