In an incredibly robust rejection of the primary psychedelic remedy to return prior to the Meals and Drug Management, a systematic advisory panel on Tuesday overwhelmingly voted towards the usage of MDMA for treating PTSD, striking its approval unsure.
On the finish of a nine-hour assembly marked by way of sometimes-emotional testimony, the advisory committee voted 9-2 that the knowledge don’t display MDMA is valuable in treating PTSD. The verdict got here after contributors critiqued the method of scientific trials by way of Lykos Therapeutics, which is looking for FDA acclaim for MDMA, and therapist oversight, quite than the drug itself.
The committee additionally voted 10-1 towards a 2d query, on whether or not the advantages of MDMA outweighed the dangers underneath the FDA’s proposed REMS program, a suite of prerequisites put on a drug to mitigate imaginable affected person harms.
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