MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?
MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?
MDMA療法用於創傷後應激障礙面臨FDA延遲：是否有其他前進的方式？
The U.S. Food and Drug Administration (FDA) has issued a complete response letter for MDMA-assisted psychotherapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times reported, this decision puts on hold what could have been a landmark approval for the treatment of PTSD with MDMA, also known as midomafetamine.
美國食品藥品監督管理局（FDA）針對MDMA輔助心理治療（MDMA-AT）治療創傷後應激障礙（PTSD）發佈了一封完整回覆函，要求進行額外的第3期試驗，以進一步評估其安全性和有效性。正如《精神病學時報》所報道的那樣，這一決定暫停了可能成爲PTSD治療的具有里程碑意義的批准，也被稱爲midomafetamine的MDMA。
Despite the setback, Lykos Therapeutics, the company behind the MDMA-AT treatment, remains determined. Lykos has expressed confidence that the FDA's concerns could be addressed using "existing data, post...
儘管遭遇挫折，MDMA-At治療背後的公司Lykos The...
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