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疗法用于创伤后应激障碍面临FDA延迟：是否有其他前进的方式？
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.
美国食品药品监督管理局（FDA）已经发布了一份完整的关于用于治疗创伤后应激障碍（PTSD）的摇头丸辅助心理治疗（MDMA-AT）的回复信，其中呼吁再进行一项3期试验，以进一步评估其安全性和有效性。正如《精神病时报》报道的那样，这一决定暂停了本来可以具有里程碑意义的用摇头丸（也称为米多马非他明）治疗创伤后应激障碍的批准。
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...
尽管遇到了挫折，但Mdma-AT治疗背后的公司Lykos T...
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