At the HLTH 2024 conference in Las Vegas, experts discussed the future of psychedelic medicines following the FDA’s decision to delay the approval of MDMA-assisted therapy for PTSD. This setback didn’t mark the end of advancements in the field, as emphasized by various professionals during a panel discussion.
Lykos Therapeutics had submitted a new drug application for this therapy which proposed to accompany the drug treatment with talk therapy. This would have been the first novel treatment option for PTSD in over two decades. However, the FDA requested an additional Phase 3 trial to further assess the treatment’s safety following preliminary issues pointed out by an independent advisory committee. These issues included poorly designed studies and allegations of sexual misconduct during earlier trials.
Shereef Elnahal, U.S. Under Secretary for Health, expressed disappointment over this delay, noting the potential impact of such therapy on veterans, a group that has been strongly advocating for these treatments. Elnahal highlighted ongoing research at the VA Rhode Island healthcare system which aims to address the FDA’s concerns, specifically mentioning a study that incorporates a low-dose MDMA placebo to tackle the problem of unblinding in clinical trials.
On a state level, initiatives such as the Arizona State Legislature’s appropriation of $5 million for psilocybin research for treating PTSD in veterans show momentum towards embracing psychedelic-assisted therapy. U.S. Senator Kyrsten Sinema underscored the importance of FDA approval for making these therapies widely accessible and safe nationwide, not only for veterans but for other individuals suffering from PTSD, including victims of sexual assault and those with traumatic childhoods.
Sinema also criticized current PTSD treatments like exposure therapy, which often result in high dropout rates due to the requirement for patients to repeatedly relive traumatic experiences. In contrast, psychedelic therapies allow patients to process their trauma more gently and effectively.
The topic of Congressional support for psychedelic-assisted therapy was brought up by Congressman Morgan Luttrell, who described the legislative process as slow and cautious. He shared his personal positive experiences with these treatments and highlighted the importance of gradual legislative implementation to avoid overwhelming the system. The conversation also touched on financial and legislative procedures to ensure the Department of Veterans Affairs and the Department of Defense could fund such treatments.
Lastly, the panel, moderated by Ruth Reader, Health and Technology reporter at Politico, discussed the logistical and financial challenges in deploying MDMA-assisted therapy post-FDA approval. The potential requirement for two therapists during treatment sessions due to previous instances of misconduct could lead to higher costs. Sinema suggested that conducting trials in group settings might reduce costs by allowing multiple patients to undergo therapy simultaneously while maintaining a manageable therapist-to-patient ratio.
The discussion also ventured into the broader implications of securing insurance coverage for psychedelic treatments post-FDA approval to ensure accessibility and affordability for patients. Thus, while the FDA’s recent decision poses a temporary hurdle, the concerted efforts by various sectors—governmental bodies, legislators, and researchers—highlight a committed path forward to integrate psychedelic therapies into mainstream medical practices for treating PTSD and potentially, other conditions.
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