FDA turns down Lykos Therapeutics new drug application for MDMA

Fairly heart-breakingly for many people suffering from PTSD and other disorders, the US Food & Drug Agency has turned down Lykos Therapeutics new drug application for MDMA. Here are more details of Lykos's initial response. Many people and organisations have responded to the FDA's disappointing thumbs down and their request for yet another Phase 3 research trial ... which will take years to do (if the FDA maintain their current position). Drug Science's carefully considered take on the various issues involved provides helpful understanding, concluding: "A decision by the FDA against the Lykos application, will cause further challenges. The huge unmet need for new and better therapies in PTSD will remain, with many patients likely to either continue to suffer, potentially committing suicide, or seeking out less safe underground therapy. We have previous experience with similar challenges with new medicines. The most famous is that of the first drugs for HIV, the access to which was too slow for patients who were dying, prompting the creation of the accelerated approvals process by lobbying the FDA for faster regulatory process and the NIH for more research [History 2022].  If MDMA does not get marketing authorisation, a model might be based on the August 2023 decision of the US Department of Health and Human Services (DHHS) to move cannabis down from Schedule I to Schedule III alongside ketamine and buprenorphine. The decision was based on an eight-factor analysis of abuse related harms [please see Table 2] and an overview of clinical use. This review was led by DHHS with input from various agencies including the FDA who agreed that cannabis met the criteria of commonly accepted medical use (CAMU) so was de-facto a medicine hence could not stay in Schedule I.  Schedule III was seen as commensurate with its low abuse potential. Current research data for MDMA in PTSD are almost certainly stronger than any medical cannabis product so the same decision could be reached, as was done by the TGA in Australia."

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