Politics
FDA Seeks Public Input On Psychedelic Research Involving Ibogaine
The Food and Drug Administration (FDA) is seeking public input on how to design research on the potential therapeutic benefits of the psychedelic ibogaine.
The agency’s request for information (RFI), released on Monday, seeks comments and data in four main areas:
- General study design, including appropriate patient populations;
- Dose selection and escalation, including the proposed use of small, sequential dose-ascending groups and a starting dose justified by available data and not exceeding 10 mg/kg;
- Safety considerations, including monitoring for cardiac and neurologic adverse events and other safeguards for clinical trials; and
- Ethical and oversight considerations, including informed consent and appropriate independent safety oversight.
The RFI comes months after President Donald Trump signed a psychedelics executive order aimed at streamlining research on and access to substances such as ibogaine and psilocybin.
“Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches,” Michael Davis, director of FDA’s Center for Drug Evaluation and Research, said. “With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first.”
A Federal Register notice accompanying the RFI notes that research on ibogaine to date has “significant limitations” and, as such, there is “uncertainty about the benefit-risk profile of ibogaine drug products.”
FDA said it is not interested in any comments on legalization or decriminalization of psychedelics, federal scheduling status, religious use or the safety or effectiveness of any specific ibogaine drug product.
Broadly, the agency said that information received through the RFI will help it “better understand the potential uses, benefits and risks of ibogaine drug products and inform approaches to drug development.”
Comments are being accepted through November 20.
The ibogaine RFI comes weeks after FDA hosted a public hearing on psychedelic therapy, with officials taking testimony from dozens of advocates, researchers and industry participants.
In July, the agency issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations.
In April, FDA issued national priority vouchers to three companies studying psilocybin for treatment-resistant depression and major depressive disorder, as well as methylone (MDMC) for post-traumatic stress disorder (PTSD), and additionally allowed an early phase clinical study of an ibogaine derivative to proceed with an Investigational New Drug (IND) submission.
FDA also signed a memorandum of understanding with the Department of Veterans Affairs (VA) concerning a partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.
Last week, a bipartisan congressional psychedelics caucus published a report on how substances like psilocybin, ibogaine and DMT can be “safely and ethically integrated” into the U.S. healthcare system, emphasizing the need for collaboration across federal agencies and with states.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said in a podcast released last month that he believes there will be an “enormous demand” for psychedelic therapies as they become legally available, and he thinks Trump is unique among his predecessors in championing the issue.
FDA and HHS in April announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
In August, the Substance Abuse and Mental Health Services Administration issued a report on recent advances in psychedelic medicine, along with recommendations for state policymakers on how to prepare for formal approval of drugs like psilocybin and MDMA. It also noted how the Schedule I status of many psychedelics has hampered scientific studies on their effects for decades.
In May, a bipartisan coalition of 32 members of Congress sent a letter urging FDA to expedite ongoing reviews of psychedelic therapies.
Lawmakers recently filed a new bill that would require the Department of Defense (DOD) to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military.
A separate recently introduced bipartisan measure is intended to codify Trump’s psychedelics executive order into law.
An amendment adopted as part of the National Defense Authorization Act would extend a psychedelics research effort at DOD for an additional six years.
Photo courtesy of Scamperdale.
