MAPS Successfully Clears Path for Cannabis Research through FDA Formal Dispute

• After three years of negotiation with the FDA, MAPS has successfully secured FDA clearance to conduct a clinical trial, MJP2, to examine the use of smoked cannabis for the treatment of PTSD symptoms among ~320 Veterans in Michigan and two other states
• MJP2’s purpose is to generate safety data about cannabis use that mirrors real-world consumption, developing an evidence base to inform medical professionals
• MAPS’ successful negotiations with the FDA will benefit future clinical researchers investigating cannabis as a potential medical treatment for serious health conditions

SAN JOSE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration (FDA) Division of Psychiatry Products has cleared the Multidisciplinary Association for Psychedelic Studies (MAPS)’ Phase 2 study of smoked cannabis in Veterans for the treatment of PTSD (MJP2) to proceed. Initially placed on partial clinical hold by the FDA in 2021, MJP2 is a randomized, placebo-controlled study of 320 Veterans suffering from moderate to severe PTSD who have previously used cannabis. Funded by the Michigan Veteran Marijuana Research Grant Program, the study is designed to investigate the inhalation of high THC dried cannabis flower, versus placebo cannabis, with the daily dose being self-titrated by participants.

Over three years, the FDA issued, and MAPS responded to, five partial clinical hold letters which halted the progression of MJP2. On August 23, 2024, MAPS responded to the FDA’s fifth clinical hold letter by submitting a Formal Dispute Resolution Request (FDRR) to resolve the continued scientific and regulatory disagreement with the Division on four key issues: 1) the proposed THC dose of the cannabis flower product, 2) smoking as a delivery method, 3) vaping as a delivery method, and 4) the enrollment of cannabis naïve participants.

“Despite the increasingly widespread use and acceptance of cannabis in patients with PTSD, labeled as ‘medical use’ in many states, there is still a lack of high-quality, controlled data on the safety and effectiveness of cannabis use that reflects real-world consumption patterns. MAPS designed MJP2 to bridge this evidence gap by studying the ‘real-world’ use of inhaled cannabis to understand its potential benefits and risks in treating PTSD.

These data are critical to inform patients, medical providers, and adult-use consumers when considering cannabis in treatment plans for the management of PTSD, pain, and other serious health conditions, yet regulatory obstacles have historically made it difficult or impossible to conduct meaningful research on the safety and effectiveness of cannabis products typically consumed in regulated markets.

The updated opinions expressed by the FDA in response to the FDRR demonstrate a willingness to recognize the value of high-quality data on the risks and potential benefits of the already-occurring widespread use of cannabis for managing PTSD. Removing barriers to research is a key part of MAPS’ mission, and we are glad to have negotiated a resolution to these long-standing obstacles in cannabis research to support all future cannabis researchers.”

Allison Coker, Ph.D., Director of Cannabis Research, MAPS

MAPS achieved a successful resolution on key issues when the FDA indicated that they would allow MJP2 to proceed with self-titration dosing of smoked cannabis with a THC potency that corresponds to what is commercially available in states permitting legal medical and/or adult-use cannabis programs.

The FDA also no longer objects to vaporization as a delivery method. However, the use of any specific vaporization device requires additional information on its mechanics to assess its safety for use with patients. Therefore, the FDA cleared the study to proceed with smoking administration but retained the partial clinical hold on the vaping device until the requested information is provided.

Additionally, the FDA maintains that cannabis naïve participants would be subject to unreasonable risk in the study. While MAPS disagrees that cannabis naïve participants smoking or vaporizing cannabis in an amount of their choosing for a 5-week period would expose them to “unreasonable and significant risk,” MAPS updated the protocol to require that all participants must have “prior experience inhaling (smoking or vaporizing) cannabis.”

“MAPS takes pride in leading the way to open new research pathways by challenging the FDA to think differently. We debated with the FDA for more than 15 years to be able to conduct rigorous research for MDMA-assisted therapy for PTSD, a novel treatment approach for FDA reviewers, then and now. Similarly, our cannabis work challenges FDA’s typical approach to scheduled dosing and administration of drugs. MAPS refused to compromise the study design in order to fit into the standard box of FDA thinking in order to ensure that cannabis research reflects cannabis use.”
Rick Doblin, Ph.D., Founder and President, MAPS

“Our Veterans are in dire need of treatments that can ease their challenging symptoms of PTSD. In my own practice, Veteran patients have shared how smoking cannabis helped them manage their PTSD symptoms more than traditional pharmaceuticals. Suicide among Veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for life-threatening health conditions like PTSD. MJP2 will generate data that doctors, like myself, can use to develop treatment plans to help people manage their PTSD symptoms.”
Sue Sisley, M.D., Principal Investigator of MJP2

In the absence of high-quality data related to cannabis, much of the information available to patients and regulators is rooted in prohibition and focused only on potential risks, without consideration of potential benefits. Within the United States, millions of Americans are smoking or vaporizing cannabis to manage or treat their symptoms. The updated opinions expressed by the FDA demonstrate a willingness to recognize the value of high-quality data on the risks and potential benefits of the already-occurring widespread use of cannabis for managing PTSD.

ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Lykos Therapeutics, a drug-development public benefit company, and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $140 million to advance psychedelic research, change drug policy, and shape culture.

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