FDA opens discussion on psychedelics in clinical trials to guide the industry

27 Jun 2023 --- As using psychedelic drugs for treating medical conditions gains interest and popularity, the US Food and Drug Administration (FDA) has issued guidance to the industry. The guidance sponsors the development of psychedelic-based treatments and has left a 60-day window for comments on the paper.

The guidance includes “classic psychedelics” such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, and the empathogen methylenedioxymethamphetamine (MDMA).

There are several challenges in conducting trials with psychedelics, and each of the same importance, a spokesperson from the FDA tells Nutrition Insight. 

The guidance works to design clinical studies to evaluate the safety and effectiveness of the compounds and to see their potential for conditions such as post-traumatic stress disorder, depression and addiction.

Psychedelic drugs are promising treatments for mood, anxiety and substance use disorders, says the FDA.“FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, the guidance describes the agency’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited,” says the spokesperson.

Mental health remedies?
Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, says that psychedelic drugs are promising treatments for mood, anxiety and substance use disorders.

“However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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 capable of supporting future drug applications,” adds Farchione.

Psychedelics and other drugs
The agency will undergo the same evidentiary standard as all other drugs to establish the effectiveness of psychedelics. Although compared to other drugs, psychedelics have unique factors that must be considered.

One difference is the role of psychotherapy in psychedelic drug development, as it requires specific considerations for safety monitoring, both during and after the treatment, as the subject might experience strong effects from the drug during treatment or a while after.

“This additional variable complicates the effectiveness assessment and presents a challenge for future product labeling,” says the guidance paper.

The FDA also says that due to psychedelics having psychoactive effects such as mood and cognitive changes and hallucinogenic effects, there is “potential for abuse of these drugs.”Compared to other drugs, psychedelics have various variables to be evaluated differently.

A recent Italian study found psilocybin and ibogaine to hold the potential for benefitting addiction withdrawal and contributing to mental well-being. The study’s author told us that we need to start separating psychedelics from drugs such as heroin, cocaine and tobacco, as the pharmacological mechanisms are different.

Science and regulations
The guidance paper further details that the efficiency of psychedelic treatment as psychotherapy has not yet been observed as efficient.

However, many scientists have recently claimed evidence to the contrary. Earlier this month, 33 researchers from eight countries found an antidepressant effect on the brain from psychedelics, with a longer-lasting and quicker effect than antidepressant drugs.

“We are facing a worldwide mental health epidemic, and new treatment methods are critically needed to overcome the shortcomings of traditional treatments. Psychedelics have the potential to shift this trajectory positively,” Matthew X. Lowe, director of research for Unlimited Sciences, previously told Nutrition Insight.

The US state of Colorado voted yes on psychedelics last November with a result of 53.4% in favor versus 46.6% against. The governor highlighted the need for innovations in mental health, while a county commissioner that voted against the legalization warned of creating a “drug hub.”

By Beatrice Wihlander