Application submission marks a significant milestone in establishing approval of MDMA-Assisted Therapy for PTSD
The Multidisciplinary Association for Psychedelic Studies' public benefit arm, MAPS PBC, has taken a groundbreaking step, submitting an application to the FDA for the approval of MDMA as a prescription medication to combat post-traumatic stress disorder (PTSD). Continue reading this news for further details.
Approval of MDMA for breakthrough therapy for PTSD treatment in the works
MAPS PBC officially submitted a new drug application (NDA) to the FDA, backed by decades of rigorous research, to seek approval for MDMA as a prescription medication targeting severe and moderate PTSD. Emphasizing the collaborative effort, the CEO of MAPS PBC, Amy Emerson, expressed that this is the hard work of over 30 years of dedicated clinical research offering a potential breakthrough for adults grappling with PTSD.
The submission follows closely after a recent Phase 3 trial published in Nature, showcasing MDMA's significant efficacy in reducing PTSD symptoms when administered alongside therapy. Having received the designation of a "breakthrough therapy" by the FDA in 2017 based on prior trials, MDMA stands poised as a promising therapeutic option.
Hope for expedited review and broader mental health research
Anticipating the potential for MDMA-assisted therapy to transform mental health treatments, MAPS PBC seeks an expedited review from the FDA. If the NDA gains approval, MDMA would mark a historic milestone as the first-ever psychedelic to be approved as a pharmaceutical to be used with psychotherapy and additional supportive services for PTSD patients.
The application's approval would necessitate the DEA to reschedule MDMA, paving the way for its regulated use in therapy. Additionally, recent studies highlighting MDMA's collaborative benefits with LSD or psilocybin in mitigating the challenging experiences associated with these psychedelics further highlight the vast potential of psychedelic-assisted therapies.
The potential approval of MDMA for PTSD treatment has brought attention to the issue on a broader scale. With ongoing discussions in various countries regarding the therapeutic potential of psychedelics like psilocybin and MDMA, this move by MAPS PBC signifies a paradigm shift in mental health treatment approaches and encourages further exploration into innovative therapeutic solutions.
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