There are currently no good medication options for PTSD, but veterans with PTSD are committing suicide at an alarmingly high rate. In 2021, there was an average of 17.5 veteran suicides per day – 6392 in total.
On May 30, 2024, the Institute for Clinical and Economic Review (ICER) reviewed the clinical effectiveness and value of methylenedioxymethamphetamine (MDMA)-assisted therapy (MAPS PBC) for the treatment of post-traumatic stress disorder (PTSD)
.
- ICER voted 14-1 against endorsing the MDMA program for treatment of PTSD. The decision was criticized for lacking psychiatric expertise and focusing excessively on the difficulty of blinding trials due to MDMA’s psychoactive effects.
- Concerns about expectancy effects led to skepticism about judging the true pharmacological impact of MDMA.
- Four days later, the FDA’s Advisory Committee (ADCOM) discussed the same topic. While there was some psychiatric representation, conventional thinking dominated the discussion.
- The panel highlighted issues such as patient expectations due to previous MDMA exposure and misconduct incidents involving therapists during trials.
- There was a strong focus on potential therapist misconduct and ethical concerns, which overshadowed discussions on the robustness of reported effect sizes and therapeutic benefits.
- The FDA’s reluctance to regulate psychotherapy despite its integral role in Lykos’ treatment approach was highlighted.
- The ADCOM voted 10-1 against supporting the efficacy of MDMA for PTSD treatment, with only two members believing in its efficacy and one seeing the benefit justifying the risk.
- This vote poses a significant challenge to Lykos’ New Drug Application (NDA), which is due on August 11, the date of the PDUFA (Prescription Drug User Fee Act).
- A rejection could slow down investment in the psychedelic sector, despite efforts by other companies to differentiate their protocols from Lykos’.
- Patients with PTSD, for whom current treatments are inadequate, face potential delays in accessing potentially beneficial therapies.
- The influence of military veterans supporting approval may be crucial in the FDA’s final decision.
- Overruling a 10-1 committee vote would be unprecedented and could signal a bureaucratic risk for the FDA.
In summary, the situation reflects a contentious regulatory landscape where traditional evaluation methods clash with innovative therapeutic approaches. The outcome will not only affect Lykos but also set precarious precedents for future psychedelic therapies and patient access to novel treatments.
