Last week, the U.S. Food and Drug Administration (FDA) made the decision not to approve MDMA-assisted therapy for post-traumatic stress disorder. This decision comes just months after advisors to the agency voted against evidence supporting MDMA therapy. The agency’s decision was based mainly on concerns about issues with clinical research.
The advisors’ decision to not approve the treatment put the agency in a bind, given that historically, it sides with this committee.
The recent news was a huge blow to Lykos Therapeutics and the broader movement focused on bringing psychedelics into mainstream mental-health care. Instead, the FDA directed that the company carry out further research on the effectiveness and safety of this treatment.
On its end, Lykos revealed that it was planning to request a meeting with the agency to reconsider its decision. Amy Emerson, CEO of Lykos, stated that the agency’s request for another phase 3 trial was disappointing. She added that carrying out the study would take a couple of years, noting that most of the FDA’s requests could be addressed with post-approval requirements, existing data or via reference to scientific literature.
The treatment had gained significant support from patients, leaders in the field of psychedelics and mental health, and politicians from both the GOP and Democratic parties.
In the last couple of weeks, advocates also organized a major campaign to apply additional pressure, calling attention to the urgent need for effective and new treatments for the millions affected by post-traumatic stress disorder, including veterans.
Research scientists at well-renowned academic centers and even the Veterans Affairs department had expressed their enthusiasm around the therapeutic potential of MDMA. This explains why so many supporters were upset by the FDA’s decision.
In its statement, the Heroic Hearts Project called the agency’s decision disgraceful, adding that this was the epitome of bureaucratic red tape and would result in even more individuals dying. This veterans’ organization had campaigned for the agency’s approval and even cited data on the many veterans who died by suicide because of PTSD.
Dr. Boris Heifets of the Heifets Lab at Stanford University noted that while the trials may have had some issues, the FDA could have dealt with these issues by approving the therapy with strict restrictions on how it’d be administered and directing that a post-market study be conducted. He also voiced his concerns that this decision by the agency would stifle innovation and reduce funding for other new treatments.
Heifets added that the agency had in the past gone against recommendations given by the committee and given the go-ahead for drugs with abuse potential.
This decision by the FDA is likely to cause other drug developers in the psychedelics space, such as atai Life Sciences N.V. (NASDAQ: ATAI), to re-examine their own programs and see how this decision could potentially impact their chances of success.
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