Collage of Petitions in the shape of word Lykos with MDMA Pills Behind It

Petition Urges FDA to Review Risks of Lykos Therapeutics’ Bid for Legal MDMA 

Scholars and concerned citizens file a public petition to the FDA to consider the unintended consequences of approving MDMA for PTSD therapy.

DoubleBlind Mag

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A cohort of five experts in psychedelics and concerned citizens have released a public petition urging the U.S. Food and Drug Administration to arrange an advisory committee session regarding Lykos Therapeutics’ (formerly MAPS Public Benefit Corp) request for MDMA approval for PTSD treatment, according to the Microdose newsletter.

“The approval of a drug-psychotherapy combination would be precedent-setting for the FDA,” the petition says. “This is a high-stakes decision with significant consequences. A public advisory committee meeting is essential to preserve the FDA’s mandate of protecting and promoting public health. As such, we call for the FDA to organize an advisory meeting for MDMA-assisted therapy (MDMA-AT) with an extended open public hearing (OPH).”

These open forums aren’t obligatory in the FDA’s approval protocol. As outlined in a commentary featured in JAMA last summer, a health policy authority noted a significant decrease in such meetings over the past decade, dwindling from 47 in 2010 to a mere 18 in 2021.

The petition seeks to initiate a meeting where the public can voice their concerns regarding the MDMA approval application. The petitioners outline various concerns about both MAPS, a non-profit organization, and Lykos, MAPS’s for-profit counterpart, spanning from safety in clinical trials to organizational culture.

“We hold serious concern that these allegations of entrapment, sexual abuse, and coercive control are directly connected to the organizational culture and psycho-spiritual beliefs around ‘healing’ that are encoded in the MAPS/Lykos protocol,” the petitioners write. 

READ: Lykos Therapeutics Highlights the Not-For-Profit to For-Profit Pipeline in Psychedelics

The petition also states that the FDA informed Lykos of a planned meeting in June 2024, but that the meeting was not publically announced, at least by the time the petition was posted.

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“This advance notice allows Lykos to organize advocates in preparation for the meeting,” the petition states. “Although the FDA stipulates that meetings must be publicly advertised at least 15 calendar days before the meeting date, other stakeholders should also be afforded the opportunity to prepare for this meeting. Additionally, given that some former clinical trial participants are disabled, advance notice is a reasonable accommodation for their full participation in the OPH. In light of strong public interest in FDA’s decision, this meeting should also be made available by webcast.”

They stress that the petition remains neutral on the FDA’s decision regarding MDMA’s approval for PTSD. As of Thursday evening, the petition has garnered signatures from 68 individuals at the time of this writing for DoubleBlind.

In an email to the Microdose, MAPS expressed unwavering support for thorough, top-tier research, meticulous safety and efficacy assessments, and rigorous regulatory supervision of all psychedelic-assisted therapy endeavors. They affirm their confidence in Lykos’ implementation of the clinical program and endorse the clinical outcomes. Lykos, in response to The Microdose, conveyed their endorsement of holding an advisory committee meeting with an open public forum. “The perspective of the PTSD patient holds tremendous significance,” they emphasized.

Read the petition here.

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DoubleBlind is a trusted resource for news, evidence-based education, and reporting on psychedelics. We work with leading medical professionals, scientific researchers, journalists, mycologists, indigenous stewards, and cultural pioneers. Read about our editorial policy and fact-checking process here.

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DoubleBlind Magazine does not encourage or condone any illegal activities, including but not limited to the use of illegal substances. We do not provide mental health, clinical, or medical services. We are not a substitute for medical, psychological, or psychiatric diagnosis, treatment, or advice. If you are in a crisis or if you or any other person may be in danger or experiencing a mental health emergency, immediately call 911 or your local emergency resources. If you are considering suicide, please call 988 to connect with the National Suicide Prevention Lifeline.

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