As the Food and Drug Administration nears a decision on MDMA-assisted therapy for PTSD, the Multidisciplinary Association for Psychedelic Studies (MAPS) appears to be recalibrating its approach.
In a recent webinar, MAPS leadership explained their reduced involvement with Lykos Therapeutics, the spin-off now steering the FDA approval process.
While top brass reiterated their support for Lykos’ approval chances, at the same time, management addressed concerns regarding what’s next in light of recent obstacles for the group. In June, an FDA advisory committee voted 1-10 against recommending approval for Lykos’ MDMA therapy, citing concerns about data reliability and safety risks. Critics, including some former trial participants, have alleged misconduct during clinical trials.
“I want to acknowledge that it did take quite some time for us to make a public statement or to reach out to you with an email or an update,” MAPS communications director Betty Aldworth said during a webinar Tuesday evening. “I know that’s been confusing, especially since you’ve counted on us for incredibly frequent updates for so many years now. And as difficult as it’s been to remain relatively quiet about the MDMA program and the FDA process, it’s also necessary.”
She added, “With the separation between MAPS, the nonprofit, and Lykos, the public benefit corporation, Lykos now fully owns the drug development and regulatory program. The Lykos communications team is responsible for deciding what to announce and when.”
In addition to the federal advisory board’s public pushback, the Institute for Clinical and Economic Review last month gave Lykos’ therapy an “I” rating, indicating insufficient evidence to assess its overall benefit. Lykos responded to the rating, calling the report “subjective.”
Even so, a group of 23 prominent researchers this week pressed for FDA approval, citing urgent need and positive trial results.
“I want to assure our supporters, while we have handed the baton to Lykos to get this priority across the line and to bring MDMA-assisted therapy to the public, whatever the results in August, we…remain committed to seeing this through,” MAP Executive Director Kris Lotlikar said.
Beyond Lykos
The team also outlined plans to focus on broader initiatives. Allison Coker, clinical research director, described a new research accelerator program that prioritizes “research that enables new investigative directions that serve the public interest” and “improves patient access and patient experience in the U.S. and globally.”
Ismail Ali, policy and advocacy director, described MAPS’ vision as “a post-prohibition future based on consciousness, not criminalization.” This includes recent efforts such as a campaign to influence the U.S. Sentencing Commission to review drug conversion tables.
Aldworth also highlighted “professional psychedelic education programs,” such as first responder training in Denver for handling emergency situations involving psychedelics.
The FDA is expected to decide on the Lykos application for MDMA therapy approval by Aug. 11. MAPS leaders say they remain committed to the broader psychedelic movement, regardless of the outcome.