Lykos Therapeutics recently voiced its dissatisfaction with the Final Evidence Report issued by the Institute for Clinical and Economic Review (ICER) concerning its MDMA Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD). Despite acknowledging that ICER recognized MDMA could be a cost-effective treatment, Lykos expressed disappointment with the report’s contents and conclusions.

Lykos Therapeutics’ Official Statement

In an official statement, Lykos Therapeutics highlighted several concerns regarding the ICER report. The company asserted, “However, like the interim report before it, the final report unfortunately goes beyond ICER’s traditional scope. It cites trial design concerns that, while important, have been and are being extensively discussed with the FDA throughout Lykos’ development program and New Drug Application (NDA) review. Further, it draws on select anonymous reports, without adequate and proper documentation, and uses these to cast unfair doubt on the integrity of Lykos, dozens of dedicated clinicians and researchers, and data from hundreds of clinical trial participants.”

Details of the ICER Report

Previously, Green Market Report covered ICER’s draft report, which concluded that the current publicly available evidence was insufficient to assess the overall net benefit of MDMA Assisted Psychotherapy (MDMA-AP), resulting in an “I” rating for the treatment. This rating implied a lack of sufficient evidence to establish a definitive benefit. Consequently, ICER decided not to provide Health Benefit Price Benchmarks for MDMA-AP based on the incomplete rating.

The final report maintained the same “I” rating and reiterated substantial concerns about the validity of Lykos’ test results. The report also outlined three key recommendations:

  1. Improve PTSD Identification: Enhance the identification of PTSD patients across diverse communities to address health inequities.
  2. Establish REMS Program: For any approved psychedelic therapy, the FDA should implement a comprehensive Risk Evaluation and Mitigation Strategies (REMS) program, including tracking adverse outcomes and rigorous certification of all healthcare providers involved in treatment.
  3. Conduct Necessary Research: Clinical researchers and life science companies should focus on the research needed to help stakeholders understand the appropriate role of psychedelic therapies in PTSD care.

Lykos Therapeutics’ Response

Lykos Therapeutics responded by accusing ICER of overlooking the complexity of developing new PTSD treatments and the pressing need for these therapies. The company reiterated its findings and criticized ICER for diminishing the significance of its research outcomes. Additionally, Lykos highlighted ICER’s undue focus on an incident of therapist misconduct from a 2015 Phase 2 clinical trial, emphasizing that the company promptly reported the incident to the appropriate authorities and permanently banned the involved therapists.

Public Comments and Controversy

Lykos suggested that only one incident of sexual misconduct occurred during its studies, but public comments attached to the ICER report painted a different picture. Several individuals reported instances of therapists crossing physical boundaries with patients. While some comments supported Lykos’ treatment, suggesting that traditional blinding methods in studies might not be suitable for psychedelic drugs, the controversy around the incidents added to the complexity of the situation.

Outlook for FDA Approval

Lykos Therapeutics remains hopeful for FDA approval of its MDMA Assisted Psychotherapy. However, the negative vote from the Advisory Council and the critical ICER report pose significant challenges. Even if approval is granted in August, the negative findings could complicate efforts to secure insurance reimbursement for the treatment, potentially hindering patient access to this innovative therapy.


What is the main criticism Lykos Therapeutics has about the ICER report?

Lykos Therapeutics criticizes the ICER report for exceeding its traditional scope by citing trial design concerns and relying on anonymous reports without proper documentation, which they believe casts unfair doubt on their research and the integrity of their clinical trials.

What are the key recommendations made by ICER in their final report?

ICER’s key recommendations include improving PTSD identification across diverse communities, establishing a comprehensive REMS program for approved psychedelic therapies, and conducting necessary research to understand the appropriate role of these therapies in PTSD care.

How did Lykos Therapeutics address the incident of therapist misconduct during their clinical trial?

Lykos Therapeutics reported the incident promptly to the appropriate authorities and banned the therapists involved from working with the company in any capacity.

Why did ICER maintain an “I” rating for MDMA Assisted Psychotherapy?

ICER maintained an “I” rating due to insufficient publicly available evidence to assess the overall net benefit of MDMA Assisted Psychotherapy, alongside concerns about the validity of Lykos’ test results.

What impact could the ICER report have on Lykos Therapeutics’ chances for FDA approval?

The negative ICER report, coupled with the Advisory Council’s unfavorable vote, could complicate Lykos Therapeutics’ efforts to secure FDA approval and make it more challenging to obtain insurance reimbursement for the treatment.

How does Lykos Therapeutics view the need for new PTSD treatments?

Lykos Therapeutics emphasizes the complexity and urgent need for new PTSD treatments, arguing that the development of these therapies is critical for addressing the mental health needs of PTSD patients.

What’s Next for Lykos Therapeutics?

Lykos Therapeutics’ journey towards FDA approval for MDMA Assisted Psychotherapy for PTSD faces significant hurdles, particularly with the critical stance of ICER’s final report. While the potential cost-effectiveness of MDMA-AP is acknowledged, the concerns raised about trial design and incidents of misconduct pose challenges. Lykos remains committed to defending its research and highlighting the need for innovative PTSD treatments. The outcome of this ongoing debate will be crucial for the future of psychedelic therapy in mental health care.