The United States may have won more gold medals at the Paris Olympics, but Australia still remains ahead of the US when it comes to legalising psychedelic-assisted therapy.
On August 9, 2024 the Food and Drugs Administration (FDA) in the US rejected a new drug application (NDA) that sought approval for midomafetamine (MDMA) capsules to treatment post-traumatic stress disorder (PTSD) in adults.
The NDA was submitted by Lykos Therapeutics, a company focused on seeking regulatory approval of psychedelic-assisted therapies. The FDA’s rejection was issued in the form of a complete response letter (CRL). According to Lykos the CRL communicated that the NDA could not be approved based on data submitted to date.
While the CRL has not been made public, in a statement released by Lykos, they noted that the rejection requested that Lykos conduct additional trials to further study the safety and efficacy of midomafetamine.
This situation contrasts with Australia’s Therapeutic Good Administration (TGA), which approved Mind Medicine Australia’s application to reschedule use of Psilocybin and MDMA for Medical Purposes back in February 2023.
Lykos’ CEO, Amy Emerson, said that FDA’s request for further Phase 3 trials would take several years, Emerson expressed their disappointment at the outcome, stating, “Our work takes place against the backdrop of a national PTSD crisis, with an estimated 13 million Americans suffering from this condition, including millions of veterans and survivors of sexual assault and domestic abuse. No new PTSD treatment has been approved by the FDA in nearly 25 years.”
However, some patient advocates have raised red flags over Lykos’ NDA, including non-profit psychedelic research group Psymposia, which applaud the rejection. Psymposia shared on X, “Lykos has a history of cover-ups, data manipulation, and egregious psychological, financial, and sexual exploitation of patients that should be exposed, not ignored. The people who counted on Lykos to conduct their trials responsibility deserved better.”
Lykos is a subsidiary of Multidisciplinary Association for Psychedelic Studies (MAPS), which made headlines when video footage of therapists spooning and pinning down a patient prompted a review of therapist conduct in MAPS’ clinical trials. In a statement following an FDA Advisory Committee Meeting, Lykos’ stated, “This was a terrible and harmful instance of malpractice that caused profound suffering to a participant. Lykos reported this violation to Health Canada, the FDA, and the relevant Institutional Review Board and banned the therapist pair associated with this case from all future work.”
While Lykos’ path has been directed to a Phase 3 trial, the FDA sits pretty. Yet, there are issues to be addressed on both sides. References in the CLR that address Lykos’ concerns about the structure and conduct of the Advisory Committee Meeting and the limited number of subject matter experts on the Advisory Panel caused this writer to do some goosenecking. Additionally, there is political pressure mounting on the FDA to be wary of, and with celebrities such as Elon Musk entering the chat, the FDA must keep a clear head.
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