MDMA therapy for PTSD voted down by FDA advisory panel - STAT
What was the vote count regarding whether the benefits of MDMA outweigh the risks under the proposed REMS program?
The vote count regarding whether the benefits of MDMA outweigh the risks under the proposed REMS program was 10-1 against.
What are the potential risks associated with MDMA that might have influenced the advisory panel's decision?
The advisory panel's decision to vote against the use of MDMA for treating PTSD was influenced by several potential risks associated with the drug. Some of these risks include:
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Cardiovascular Effects: MDMA can lead to both increased heart rate and blood pressure. The FDA raised concerns about the potential for these effects to trigger serious issues such as myocardial infarction, central nervous system hemorrhage, and aortic dissection.
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Psychological Distress: There are concerns about the potential for MDMA to cause severe psychological distress and worsening suicidal ideation. The FDA highlighted the need for additional safety assessments, including laboratory tests before and after treatment.
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Addiction Potential: MDMA is known to produce feelings of euphoria, which raises concerns about its potential for abuse and addiction.
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Study Design and Data Validity: The FDA and the advisory panel raised concerns about the design of the clinical trials conducted by Lykos Therapeutics. They questioned whether the findings from the trials are solid, as most people in the trials could tell whether they received MDMA or a placebo, which can lead to bias and skew the results.
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Long-term Benefits and Safety: The panel also questioned how long the benefits of MDMA treatment might last, noting that about a quarter of patients quickly dropped out of the follow-up study, limiting the usefulness of the results.
These potential risks and the concerns about the validity of the clinical trial data led the advisory panel to vote against the approval of MDMA for treating PTSD.
What are the next steps for Lykos Therapeutics following the advisory panel's decision?
Following the advisory panel's decision, Lykos Therapeutics may consider several next steps in their pursuit of FDA approval for MDMA-assisted therapy for PTSD:
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Addressing the concerns raised: Lykos Therapeutics can analyze the concerns and critiques raised by the advisory committee regarding the methodology of their clinical trials and therapist oversight. The company can then work on addressing these issues and possibly conduct additional studies or trials to strengthen their case for approval.
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Resubmitting the application: After addressing the concerns and gathering more data, Lykos Therapeutics can resubmit their application to the FDA for reconsideration. This process would involve presenting the new evidence and demonstrating how the company has addressed the concerns raised by the advisory panel.
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Appealing the decision: Lykos Therapeutics could explore the possibility of appealing the advisory panel's decision. This process would involve presenting new evidence or arguments that may sway the FDA's opinion on the matter.
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Seeking alternative regulatory pathways: If the FDA remains reluctant to approve MDMA-assisted therapy for PTSD, Lykos Therapeutics could explore alternative regulatory pathways for their treatment. This may involve seeking approval in other countries with different regulatory frameworks or pursuing approval for a different indication (e.g., another mental health condition).
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Collaboration and partnerships: Lykos Therapeutics could consider collaborating with other companies, research institutions, or non-profit organizations to further develop and validate their MDMA-assisted therapy4. Partnerships can provide additional resources, expertise, and credibility that may help in gaining regulatory approval.
It is essential for Lykos Therapeutics to carefully consider their next steps and develop a strategic plan to address the concerns raised by the advisory panel and the FDA. This will be crucial for the company's pursuit of approval for MDMA-assisted therapy for PTSD and their mission to transform mental healthcare.