Psychedelic stocks hit after FDA advisors snub MDMA treatment for PTSD
Psychedelic medicine stocks were hit on Wednesday after the US Food and Drug Administration (FDA) rejected an MDMA-based treatment for post-traumatic stress disorder (PTSD).
Lykos Therapeutics' MDMA-assisted therapy was not recommended by an FDA advisory panel, with the agency’s advisors taking the view that the benefits do not outweigh the risks of taking MDMA (the active compound in ‘ecstasy’).
It was a blow not just for Lykos, but also the broader psychedelic medicine sector – with shares in companies developing other treatments falling in the morning’s deals.
Psyche stocks drop
Mind Medicine Inc. (MNMD), which is developing an LSD-based treatment for generalized anxiety disorder, was down around 10% whilst Compass Pathways PLC (CMPS), studying psilocybin for depression, fell 13%.
A final FDA decision for Lykos’s MDMA drug is expected later this summer, though experts note that the agency often aligns with the recommendations of its advisors.
Lykos chief executive Amy Emerson said the company was disappointed by the outcome, whilst highlighting an “urgent unmet need” for people suffering from PTSD.
Emerson noted, however, that she appreciated that “he committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention”
The company’s new drug application to the FDA included the findings of two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) which confirmed the efficacy and safety of MDMA used in combination with psychological intervention including talk therapy provided by a qualified healthcare provider.
“Research has suggested the unique properties of MDMA may act as a catalyst to enhance psychotherapy, the current standard of care, by helping diminish the brain's fear and avoidance responses and extend the window of tolerance of painful emotions and memories, thereby allowing people to access and process painful memories without being overwhelmed,” said Jerry Rosenbaum, a Director of the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital Research Institute.
Remaining committed
Amy Emerson, meanwhile, added: “We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.
“We are grateful to the advocates, clinical trial participants and people living with PTSD who shared their testimony in the open public hearing and through written comments, and will continue to do everything we can to bring this potential new therapeutic option to people living with PTSD."
