Jan 20, 2022
What is MAPS and what do they do?
The Multidisciplinary Association of Psychedelic Studies otherwise known as (MAPS), a nonprofit organization who has been dedicated to researching the legal and medical benefits of psychedelic medicine for mental health has worked in collaboration with the Food and Drug Administration over the past 32 years researching the benefits and barriers of MDMA Assisted Therapy for Post Traumatic Stress Syndrome, pain treatment, depression and anxiety.
On January 5, 2024, MAPS Public Benefit Corporation a subsidiary of its overarching nonprofit organization changed its business strategy and name to Lykos Therapeutics, a privately held firm, after raising over 100 million dollars from outside investors.
MAPS PBC originally functioned as a drug development and manufacturing company whose purpose was to help MDMA clinical trials complete the FDA Drug Approval Process.
The checks and balances between the MAPS Nonprofit entity and MAPS PBC were intended to help the organization remain true to its mission to prioritize patient well-being over profit.
However, in 2023, MAPS began to struggle financially which impacted several of their clinical trials. MAPS PBC stakeholders made the decision to open their doors to outside investors in order to secure necessary funding to continue research and complete clinical trials.
Understanding MAPS and the FDA
MAPs has worked with the FDA since 1986 filing applications for permission to conduct research regarding the therapeutic benefits of MDMA. In 1992, the FDA approved its first MAPS supported protocol for MDMA for the treatment of pain, anxiety and depression in cancer patients.
FDA Breaththrough Therapy
After 25 years of research, in 2017, the FDA granted MDMA Assisted Therapy for PTSD the Breakthrough Therapy Designation and agreed to a special protocol assessment for MAPS Phase 3 Clinical Trials.
Independent FDA Advisory Committee and the FDA Drug Approval Process
In 2024, the FDA’s final approval application for MDMA Assisted Therapy would be up for review. In June 2024, an independent FDA Advisory Committee, which consists of representatives from a variety of industries, voted against the approval of MDMA Assisted Therapy as a result of their concerns with the research submitted by MAPS, now Lykos Therapeutics, to the FDA in March 2024.
The Advisory Committee’s expressed three major concerns:
Members of the advisory committee were concerned that the clinical trials submitted by Lykos Therapeutics to the FDA in March 2024 exhibited significant bias in it’s data.
Advisors questioned missing information about safety and bias in the efficacy of its research. In other words, the Advisory Committee argued the MAPS, now Lykos Therapeutics, Phase 3 Trials for MDMA submitted to the FDA in March 2024 did not provide sufficient evidence of double-blind procedures. Double blind procedures are designed to minimize bias in research by ensuring the researchers and participants are both unaware of their assigned study groups.
Advisors also questioned the lack of diverse representation in its study population and the minimal use of triangulation methods for data collection designed to check for consistency.
The advisors were also concerned with the study’s unanswered questions about MDMA’s potential for abuse and the impact of psychotherapy in the study’s results.
Although the FDA does not regulate psychotherapy, the advisors were very curious as to which psychological approaches were used in the treatment model and how those various approaches impacted the overall outcomes.
All very valid questions and concerns. However, these questions and concerns were not a dismissal of the validity of the therapeutic treatment or the medical potential for MDMA.
These are the questions that the FDA advisory committee were tasked to ask. The FDA advisory committee is a check and balance. It’s designed to protect the public and ensure ethical research practices.
Below are a few statements from members of the FDA advisory committee noted by Deidra McPhillips of CNN,
“I absolutely agree that we need new and better treatments for PTSD, especially in the somatic treatment space. However, I also note that premature introduction of a treatment can actually stifle development and stifle implementation and lead to premature adoption of treatments that are either not completely known to be safe not fully effective or not being used at their optimal efficacy,” said Dr. Paul Holtzheimer, deputy director for research at the National Center for PTSD.
As a member of the advisory committee, he voted against the treatment. “I think this is a really exciting treatment. I’m really encouraged by the results to date, but I feel that both from an efficacy and a safety standpoint it is still premature.”
"Dr. Walter Dunn, a staff psychiatrist at the Veterans Administration Greater Los Angeles Healthcare System and assistant clinical professor of psychiatry at the University of California Los Angeles, was the only committee member to vote in favor of the treatment on both questions of efficacy and the balance of risks and benefits.
His confidence in the risk-benefit analysis was low, he said; psychotherapy is an integral component of this treatment program, and it could be “the greatest strength of the treatment” but “also its greatest liability” – and it’s not within the FDA’s scope to regulate, he said. And specific guardrails the FDA outlined to be put in place with approval of the treatment to protect patient safety were incomplete.
'Ultimately, I’m voting yes because I’m putting on my clinician hat,” Dunn said. “Working in the VA, as a former servicemember myself, I have colleagues who deployed who have PTSD, and this has the potential to make a to make a difference. Now, that’s not without its risks.'”
So what’s next for MAPS and MDMA?
After the FDA’s decision, MAPS now Lykos Therapeutics, made additional decisions to adjust its business strategy in order to address the FDA concerns.
In it's restructure, Lykos Therapeutics laid off 75% of its staff and announced key changes to the company’s senior management.
Rick Doblin (MAPS Founder) resigned from the Lykos Therapeutics board to focus on the nonprofit and MAPS advocacy.
After Doblin's resignation, the Lykos Therapeutics board appointed Mike Mullette, a pharma veteran and Lykos Therapeutics previous Chief Operating Officer, as the interim CEO.
Lykos also named Dr. David Hough as its Chief Medical Officer and has positioned itself with Pharma veterans to work with the FDA for the medical approval of MDMA.
Most importantly, there is still hope for those seeking alternative mental health medicines and therapies.
Experts are not denying the medical benefit of MDMA, they have simply recommended Lykos Therapeutics refine the delivery method to better ensure safe medical treatment and therapeutic practice.
I look forward to seeing how it develops.
Fanicy Sears, LPC-S, LMFT, NCC
Clinical Director
eMotion Therapy, LLC
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