News just out ... the US FDA plans to respond to MAPS/Lykos MDMA licensing application on August 11th

Yesterday it was announced that the US FDA plan to respond to the MAPS/Lykos MDMA licensing application on 11th August ... just six months away now! MAPS comment: "The Multidisciplinary Association for Psychedelic Studies (MAPS) congratulates Lykos Therapeutics, formerly MAPS Public Benefit Corporation, on its announcement that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for midomafetamine capsules used in combination with psychological intervention for individuals with PTSD. The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024 to make the review determination." Subsequent DEA rescheduling might take two or three more months ... so, MDMA may well be available for prescription use in the USA by this autumn. In the UK, the new International Recognition Procedure came into force on the 1st January.  This means that if MDMA receives FDA approval this August (which seems very likely), then the UK Medicines & Healthcare products Regulatory Agency (MHRA) will recognise MDMA within either a 60-day or 110-day timeline.  Since the UK has already given MDMA an approval-speeding Innovation Passport, it seems likely that MDMA licensing will follow the 60-day timeline, leading to UK licensing by the autumn as well.  Lots of fingers crossed!

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