…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,…
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…
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…
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…
…this will… be the first time in 25 years that the FDA will review a new treatment for PTSD… The FDA is set to decide on the therapy’s fate by the middle of August [2024]… if rescheduled, then lobbying efforts will shift to individual states. Some have policies on the books that will immediately follow…
At first, the goal was to use psychedelics to heal veterans (as indicated by MAPS’s public relations between 2005 and 2012). Then, in 2012, Doblin shifted to suggesting that psychedelics might be used to heal traumatized active-duty soldiers. Now, MAPS’s founder calls for military recruits to be dosed upon enlistment. This latest turn was announced…
It would be one thing if arguments against the decriminalization of psychedelics were being made. But that’s not the case. Instead, the lumping together of psychedelics and opioids seems to have gone largely unnoticed, setting up personal use of psychedelics to become an unintended casualty of Oregon’s opioid crisis. By treating all drugs as an…
[Oregon is poised to legislate the return to recriminalizing personal possession of psilocybin-containing mushrooms (as well as LSD and MDMA) on Tuesday March 12, 2024; with citizens awaiting Democratic Governor Tina Kotek’s signature to do so.] “There is more awareness when it comes to psychedelics, especially mushrooms,” Valera said. Salem City Councilor Andy Varela believes…
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…
The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday [12/12/23] that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy. If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly.…
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