A key independent drug pricing organization has concluded that the available evidence for Lykos Therapeutics’ MDMA-assisted psychotherapy is “insufficient” and it can’t be compared to other psychotherapies.
ICER’s comment adds insult to injury for the biotech. Earlier this month, FDA advisors overwhelmingly voted that the benefits of the treatment didn’t outweigh the risks, and criticized the conduct of the company’s trial, including how it collected data on the potential for abuse.
Included in ICER’s final report Thursday were two similar votes from the group’s New England Comparative Effectiveness Public Advisory Council. The 15-person panel voted unanimously that the available evidence from Lykos was inadequate to demonstrate a health benefit over other short-term, trauma-focused psychotherapies. The group also voted 14-1 that the evidence didn’t demonstrate a health benefit over not treating patients with MDMA-assisted psychotherapy.
Lykos has been testing the psychedelic MDMA alongside psychotherapy for patients with PTSD, which has seen little therapeutic advancement in the last two decades. Only two selective serotonin reuptake inhibitors have been approved by the FDA for treatment.
The ICER report is packed with concerns about the trial’s data and ethics, as expressed by unnamed participants in Lykos’ trial. One of the more explosive anecdotes ICER referenced, which has not been independently verified by Endpoints News, is that “sexual boundaries” were crossed with at least one patient in Lykos’ Phase 2 study. ICER used the case as an example of how patients could be exploited while receiving MDMA-assisted treatment.
“Nearly everyone we spoke with discussed how MDMA breaks down barriers, heightens suggestibility, and creates a substantial risk with any therapists who might choose to take advantage of patients,” the report authors wrote.
Amy EmersonLykos CEO Amy Emerson said in a statement that the company “reported that incident in a timely manner to the appropriate authorities and banned the therapists from working with Lykos in any capacity.”
“The company is committed to working with regulators, licensing boards, centers of care, and other stakeholders to ensure robust systems are in place to help protect patients and mitigate the risk of misconduct of any kind,” Emerson said.
ICER also raised concerns, as FDA advisors did, about the difficulty of blinding study participants, noting that 94% of patients that received MDMA correctly guessed that they were not on a placebo. The report concluded that there was a high risk of bias in the study.
Emerson said that ICER’s report “relies on subjective analysis in a manner that seems misaligned to the data-driven approach ICER is meant to provide.”