VANCOUVER, BC, June 7, 2024 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a leader in mental health care specializing in innovative and evidence-based treatments, comments on the results of June 4, 2024 meeting of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"). The independent committee reviewed Lykos Therapeutics' new drug application for MDMA (midomafetamine capsules) used in combination with psychological intervention for individuals with post-traumatic stress disorder ("PTSD"). The PDAC voted against recommending approval of MDMA for PTSD in a majority decision where 2 of 11 found that the available data demonstrates MDMA's effectiveness in PTSD patients, and one committee member found that the benefits of MDMA outweigh its risks for treating PTSD patients based on available data. The FDA is expected to decide on Lykos' new drug application in August this year and is not bound by the PDAC's guidance. Advisory committees, like PDAC, make non-binding recommendations to the FDA. Historically, between 2010 and 2021, the FDA approved subject treatments in 97% of cases where the committee recommended approval and in 33% of cases where the committee recommended against approval.1 There can be no assurance as to the FDA's decision with respect to Lykos' MDMA new drug application.
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