On June 23, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance[1] outlining clinical trial considerations for drug sponsors involved in the medicalization of psychedelics.[2] This is the FDA’s first guidance focusing on psychedelic drug development.
Although psychedelic drug developers must abide by the same regulatory and evidentiary standards as other drug developers, the FDA’s draft guidance recognizes that psychedelic drug developers face additional unique challenges when designing clinical trials involving psychedelics.
In a press release,[3] the director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, Tiffany Farchione, M.D., noted that psychedelics “show initial promise as potential treatments for mood, anxiety and substance use disorders.” She further stated: “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
The draft guidance offers general considerations as they apply to the psychedelic drug development process, including sections on submission of chemistry data and manufacturing compliance, pharmacokinetic/pharmacodynamic and dose-response characterization, abuse potential determination, and design of adequate and well-controlled clinical studies. Within the various sections, the FDA provides more detailed explanations and solutions to some of the challenges specific to the medicalization of psychedelics, but notes that its goal was not to provide specific recommendations, but rather to “present foundational constructs.”[4] Examples of some of the more challenging aspects of psychedelic drug development identified by the draft guidance include:
The FDA will accept public comment within 60 days of the publication of the draft guidance.
Tiffany Farchione noted: “Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”[18]
Phillips Lytle’s expertise in pharmaceutical sciences, FDA regulatory compliance, and pharmaceutical product liability litigation and risk management enables it to address complex legal hurdles faced by stakeholders seeking to research, develop, invest in and bring-to-market psychedelic therapies.
Eric M. Kraus is a partner at Phillips Lytle LLP and member of the firm’s Psychedelics & Mental Therapeutics Practice Team. He can be reached at (212) 508-0408 or ekraus@phillipslytle.com.
Lisa L. Smith is a partner at Phillips Lytle LLP and leader of the firm’s Psychedelics & Mental Therapeutics Practice Team. She can be reached at (716) 847-8336 or lsmith@phillipslytle.com.
Julia M. Markov, Pharm.D., is a science specialist at Phillips Lytle LLP and member of the firm’s Psychedelics & Mental Therapeutics Practice Team. She can be reached at 716-847-5442 or jmarkov@phillipslytle.com.
[1] FDA, Psychedelic Drugs: Considerations for Clinical Investigations, Guidance for Industry, Draft Guidance (June 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations.
[2] For the purposes of the guidance, the FDA used the term “psychedelic” to refer to the classical psychedelics such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).
[3] FDA News Release, FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs, Agency Recommendations Aim to Inform Psychedelic Drug Development (June 23, 2023), https://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs.
[4] FDA, supra note 1, at 2.
[5] FDA, supra note 1, at 6.
[6] FDA, supra note 1, at 2-3.
[7] FDA, supra note 1, at 4.
[8] FDA, supra note 1, at 8-9.
[9] FDA, supra note 1, at 9.
[10] FDA, supra note 1, at 9.
[11] FDA, supra note 1, at 9.
[12] FDA, supra note 1, at 10.
[13] FDA, supra note 1, at 5.
[14] FDA, supra note 1, at 4, 5, 10.
[15] FDA, supra note 1, at 10-11.
[16] FDA, supra note 1, at 5, 10.
[17] FDA, supra note 1, at 10.
[18] FDA, supra note 3.
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