Lykos Therapeutics Faces FDA Advisory Panel Challenges

The TDR Three Key Takeaways regarding Lykos Therapeutics and FDA Rejection:

  1. Lykos’ MDMA therapy trial execution was found problematic by the FDA panel.
  2. Trial design flaws, including poor blinding, impact Lykos’ FDA approval.
  3. Lykos must refine trial designs to meet FDA standards for approval.

In this episode of the “Trade to Black” podcast, Daniel Carcillo, former NHL Stanley Cup champion and psychedelic advocate, discussed the FDA advisory panel’s decision to reject Lykos Therapeutics’ MDMA-assisted therapy for PTSD. The conversation offered insights into the trial’s shortcomings and the broader implications for psychedelic treatments in mental health.

Carcillo emphasized the critical errors made by Lykos Therapeutics, stating, “If I was the GM of an NHL team or overseeing Lykos, I would take a serious look under the hood internally and figure out who made the mistakes and start cleaning up.” This reflects a concern about the trial’s execution and data integrity, which the FDA panel found problematic.

The panel’s decision came after two Phase 3 clinical trials involving nearly 200 patients with moderate to severe PTSD. While the trials showed promising results, with 86% of participants experiencing symptom reduction, the FDA cited issues such as poor blinding and potential biases, raising doubts about the reliability of the data.

Anthony Varrell, co-host of the podcast, pointed out the inherent challenges in maintaining a blind in MDMA trials due to the drug’s distinctive effects. “If you’re taking MDMA, you know that you’re taking MDMA. It’s not an experience that you’re not going to be able to feel,” he noted, highlighting a fundamental issue in psychedelic research.

Despite the setback, there remains hope for the approval of MDMA-assisted therapy. Carcillo expressed optimism, suggesting that with improved trial designs and addressing FDA concerns, the therapy could still gain approval in the future. He stated, “I believe that you can reapply. It just might take a little longer.”

The podcast also explored broader issues within the psychedelic treatment field, including the need for accurate clinical protocols and the impact of potential regulatory changes. Carcillo stressed the importance of accountability and learning from this experience to ensure future success. “Clinical trial design is extremely important to obviously get a substance or medicine approved through the FDA. It’s even more critically important if you are trying to do something novel,” Carcillo explained.

Varrell emphasized the need for Lykos Therapeutics to learn from these mistakes and improve its approach. “We need a clear pathway for reporting and ensuring patient safety. This is crucial for moving forward,” he remarked, highlighting the importance of safety protocols.

The panel’s decision is not just a setback for Lykos Therapeutics but for the broader movement advocating for the medical use of psychedelics. The trial’s flaws highlight the need for more strong and innovative clinical designs that can withstand rigorous scrutiny.

Carcillo voiced the sentiment of many advocates, stressing the potential of MDMA to transform PTSD treatment. “There’s always a chance for approval. This is not the end, just a call to refine our methods and approach,” he said. He further added, “The first through the wall is bloodiest. We’ll see how they course correct.”

Varrell also noted the importance of community support and shared learning within the industry. “The data was promising but given the 40% of people who had previously used MDMA, limited information about recruitment and recruitment coming through referrals — I really wonder how much that impacted the efficacy,” he said, reflecting on the impact of trial design on results.

Moving forward, Lykos Therapeutics needs to address the highlighted issues. The company must refine its trial designs to meet the FDA’s standards and ensure that any future data submitted is beyond criticism. Carcillo suggested a detailed review and restructuring of their clinical approach, emphasizing, “Accountability and diligence are key to overcoming this hurdle.”

The potential rescheduling of cannabis at the federal level, discussed by Carcillo, could also influence future psychedelic research and its regulatory outlook. The legislative environment presents both challenges and opportunities for companies in this space. Carcillo highlighted the importance of keeping advocacy efforts strong, “This is why I have always advocated for all three: decriminalization, statewide programs, and FDA-approved synthetic medicines. You should always advocate for all three because you can’t rely on a loving government to have your back.”

While the FDA’s rejection is a significant hurdle, it also serves as a critical learning opportunity for Lykos and the broader psychedelic community. By addressing the flaws highlighted by the FDA and refining their approach, there is still a pathway forward for MDMA-assisted therapy, offering hope for millions suffering from PTSD. Want to be updated on all things Psychedelic, Cannabis, AI, and Crypto? Subscribe to our Daily Baked in Newsletter!

You might also like

This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Accept Read More