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), requesting an additional phase 3 trial to further assess its safety and efficacy. This decision delays what could have been a groundbreaking approval for MDMA, also known as midomafetamine, as a treatment for PTSD.
Lykos Therapeutics, the company behind MDMA-AT, remains committed despite the setback. They believe the FDA’s concerns could be addressed with existing data, post-approval requirements, or by referencing scientific literature. Ongoing discussions with the FDA aim to establish a clear path forward for the treatment. told by BBC.
Other Psychedelic Therapies Making Progress
While MDMA’s future is uncertain, several other psychedelic treatments are advancing in clinical trials. Atai Life Sciences has reported promising results from a phase 1b trial of VLS-01, a buccal film formulation of N, N-dimethyltryptamine (DMT), for treatment-resistant depression. A phase 2 study is expected to begin by the end of 2024, focusing on the treatment’s safety, efficacy, and durability.
Numinus Wellness is progressing with studies on Cybin’s CYB003, a deuterated psilocybin molecule designed to treat moderate to severe depressive disorders. Compass Pathways is also advancing with COMP360, a synthetic psilocybin formulation that has shown encouraging early results for PTSD treatment. These developments underscore the ongoing efforts to explore psychedelic-assisted therapies for various psychiatric conditions.
Advancements in LSD and Ketamine Treatments
MindBio Therapeutics is making strides with MB22001, a microdosing form of LSD, in phase 2a trials for major depressive disorder (MDD). The company is also exploring LSD’s potential for treating conditions such as premenstrual dysphoric disorder and cancer-related depression. MindMed is advancing its LSD compound, MM-120, aimed at treating generalized anxiety disorder (GAD), with a phase 3 trial set to launch this year.
Ketamine-based therapies are also progressing, with Awakn Life Sciences leading research on ketamine infusions combined with psychosocial support for treating alcohol use disorder through their MORE-KARE phase 3 trial. report from The Week.
Lykos Therapeutics and the Future of MDMA
As the psychedelic landscape evolves, Lykos Therapeutics is under the spotlight as it addresses the FDA’s requirements for MDMA-assisted psychotherapy. The company has recently reorganized, reducing its workforce by 75% and appointing Dr. David Hough, an experienced psychiatric drug developer, as senior medical advisor to guide the next phase of clinical work. Dr. Hough previously led successful projects, including the development of Spravato.
Rick Doblin, PhD, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has resigned from the Lykos Board to focus on advocating for global access to MDMA and other psychedelics. His departure comes as Lykos continues its negotiations with the FDA.
Looking Ahead
Despite the current challenges for MDMA-assisted psychotherapy, the broader field of psychedelic research remains dynamic, with over 185 clinical studies on psilocybin, 104 on MDMA, and 58 on LSD ongoing, according to clinicaltrials.gov. As these studies progress, there is growing optimism that these novel therapies will soon become more accessible to patients in need.
