Last week, the U.S. Food and Drug Administration (FDA) rejected a new drug application for MDMA to be administered as treatment for post-traumatic stress disorder. In its rejection, the federal agency asked the company that filed the application, Lykos Therapeutics, to conduct additional trials to further study the effectiveness and safety of its psychedelic formulation.
This would require additional funding as well as a number of years to complete, which doesn’t align with Lykos Therapeutics’ expectations.
The FDA’s ruling left many upset, particularly experts and patient advocates involved in the development and research of psychedelic treatments.
One neuroscientist at the University of California-San Francisco, Jennifer M. Mitchell, stated that the decision was a disappointment, adding that those involved in the application were confident they had met the criteria requested by the agency. Retired brigadier general Stephen Xenakis explained that these therapies were urgently required, not only by veterans but also other individuals experiencing similar problems.
Lykos Therapeutics is yet to make the letter of rejection available to the public. However, in a statement, the company stated that the issues voiced by the FDA were similar to those raised during an advisory committee meeting held a couple of months ago. The meeting was led by a panel of psychiatric experts who raised concerns about the safety and effectiveness of MDMA.
One of the issues raised was the inability to differentiate the psychedelic from the placebo effect as most participants in the trial could correctly guess whether they had received the placebo or the psychedelic.
Lykos revealed that it had responded to these issues, taking into account the suggestions raised and minimizing the effects of the issue.
Post-traumatic stress disorder affects roughly 13 million individuals in the United States, with current treatments only benefitting a fraction of these. The condition disproportionately affects veterans, with about 19% and 10% of female and male veterans respectively diagnosed with the disorder in 2021. Data from the Department of Veterans Affairs also shows that roughly 17 veterans die by suicide daily.
Prior to the FDA’s ruling, 730 veterans and 80 bipartisan legislators penned different letters to President Joseph Biden imploring him to approve the therapy.
Lykos plans to schedule another meeting with the agency where it will request that the FDA reconsider its ruling to conduct another trial. During the meeting, the company hopes to convince the agency to allow it to use existing data to file a new application instead. If the FDA declines this request, it is unclear what the company’s next step will be.
The entire psychedelics industry, including companies such as Compass Pathways PLC (NASDAQ: CMPS), will be anxiously waiting to see how this matter is concluded and any potential impact it may have on other psychedelics drug candidates under development.
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