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…

READ MORE
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…

READ MORE
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…

READ MORE
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…

READ MORE
Politics

We’re on the cusp of another psychedelic era. But this time Washington is along for the ride

Advocates still must overcome stigma associated with 1960s drug culture and concerns about side effects, but they’ve never enjoyed such strong support inside government… federal agencies are signaling a willingness to cooperate… If Washington assents, manufacturers are poised to deliver. In the House, Democrats including Alexandria Ocasio-Cortez of New York and Lou Correa of California, and Republicans led by Dan…

READ MORE
Politics

FDA issues first draft guidance on clinical trials with psychedelic drugs

The purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics. Within the draft guidance, the term psychedelics refers to “classic psychedelics,” typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, as…

READ MORE
Biography/Memoir

So MDMA, psilocybin are medicines – now what?

Australia is known as among the most conservative medical communities in the Western world… the approval has sent professional bodies into a flurry, caught off guard and seemingly outflanked by those outside the tent. While there are several countries such as the United States, Canada, Switzerland and Israel where psychedelics can be used outside of…

READ MORE
Biography/Memoir

…administration plans for legal psychedelic therapies within two years

…letter from the Health and Human Services Department discloses the anticipated FDA approval of MDMA and psilocybin treatments… the May [2022] correspondence, not shared publicly until now, is the clearest indication yet that top officials are preparing for the approval of psychedelic drugs – demonized for decades after former President Richard Nixon sought means to…

READ MORE
Science

…open science approach to… MDMA [& psilocybin]

Instead of holding on tightly to trade secrets… MAPS paper… read as a step-by-step production recipe, the study maps out how MDMA with a purity of 99.4% can be made from non-controlled substances… describes a process of making MDMA according to “current Good Manufacturing Processes” (cGMP), with the end product being 30.000 (167mg) individual doses……

READ MORE
Medicine/Healing

FDA… approves study allowing therapists to legally use MDMA

The United States Food and Drug Administration, in a landmark decision, just approved… …a new clinical study that allows therapists who want to conduct MDMA-assisted therapy sessions to legally consume the drug themselves.  Original Article (Microdose Buzz):FDA historically approves study allowing therapists to legally use MDMAArtwork Fair Use: Public Domain

READ MORE