At Bonaventure Equity, we aim to bring you perspectives from the front lines of investing in controlled substances, delving beyond the headlines in this dynamic field.
Another significant event unfolded last week that warrants deeper analysis.
Overview
Today, we’re addressing the recent news that has stirred the psychedelics community — the FDA’s decision to reject Lykos’ application for MDMA as a treatment for PTSD.
We believe this decision, while initially perceived negatively by many, is a positive step towards ensuring the safe and effective use of psychedelics in medical treatments.
- Overview
- The News
- Why it matters
- Why MDMA isn’t like other psychedelics
- FDA’s Encouragement for Further Research
- Concerns Voiced at the Advisory Committee Meeting
- Our Stance
- A Note on Patients
- Looking Forward
- Some Of The Headlines We’re Reading
- Be Part Of The Conversation in our Upcoming Webinar
The News
On Friday of last week, the FDA issued a Complete Response Letter to Lykos detailing concerns and requesting additional information, including the completion of another Phase 3 study.
The agency’s decision reflects the advisory committee’s earlier concerns about the study’s design, data integrity, and the lack of clear evidence that MDMA’s benefits outweigh its risks.
Why it matters
The FDA’s rejection of Lykos’ MDMA application for PTSD treatment is a pivotal moment in the psychedelic medicine landscape. The decision emphasizes the importance of patient safety and underscores the need for rigorous research standards.
Why MDMA isn’t like other psychedelics
It’s important to differentiate MDMA from other psychedelics. While often grouped together, MDMA possesses a significantly higher potential for addiction and dependency. Unlike substances such as psilocybin or LSD, MDMA’s unique chemical composition and effects on the brain make it more prone to abuse. Ensuring distinct regulatory pathways for different psychedelics is crucial for both patient safety and industry credibility.
FDA’s Encouragement for Further Research
Despite the rejection, the FDA has encouraged Lykos to continue their Phase 3 study. This clear indication of potential underscores that while progress is being made, the current Lykos study does not yet meet the rigorous standards required for clinical trial approval. The FDA’s stance is not a dismissal of psychedelic research but a call for more robust evidence and participant safety.
Concerns Voiced at the Advisory Committee Meeting
During the advisory committee meeting, there were serious concerns raised about the data integrity and the ethical treatment of participants in Lykos’ study. These are critical factors that must be addressed before MDMA can be considered a viable treatment option. The “no” vote from the advisory committee reinforces the need for comprehensive and ethically conducted research.
Our Stance
We support the FDA’s decision as it aligns with our commitment to ensuring safe and effective psychedelic treatments. It serves as a reminder of the importance of rigorous clinical trials and ethical research practices in advancing these innovative therapies.
A Note on Patients
We are working every day in the ultimate service of patients who need these treatments. Much of Lykos response is centered around how this decision impacts veterans and people suffering with PTSD. Yes, there is no question that we need to push forward to treat these insidious diseases and patients and families who need solutions. But we must temper this response in the context that this argument is applicable to every drug that does not receive FDA approval.
Looking Forward
Our focus remains on supporting research and development that adhere to the highest standards of clinical trial conduct. We believe that, with time and careful study, psychedelics can offer groundbreaking treatments for a range of mental health conditions.
Thank you for your continued interest and investment in the future of psychedelics. We appreciate your support as we work towards a safer, evidence-based future for these promising therapies.
Some Of The Headlines We’re Reading
Here are a few of the headlines:
- lycospbc.com: Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD
- biopharmadive.com: In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD
- npr.org: FDA gives thumbs down to MDMA for now, demanding further research
- science.org: FDA rejected MDMA-assisted PTSD therapy. Other psychedelics firms intend to avoid that fate
- hklaw.com: FDA Rejects Application for Psychedelic Drug
Be Part Of The Conversation in our Upcoming Webinar
Join us for a live webinar on this topic where we’ll explore this news and more. Stay tuned for details right here and through our newsletter.
