The Food and Drug Administration (FDA) recently made a significant decision regarding the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder (PTSD). Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the FDA had declined to approve the company’s application for the use of MDMA in PTSD treatment. This decision marks a pivotal moment in the field of psychedelic drug development, as it is the first time such a decision has been issued on a psychedelic drug application.
Many investors and researchers had been anticipating a potential boom in the psychedelics industry, with MDMA being just the first of a number of psychedelics in the drug development pipeline. The FDA’s decision to deny approval for MDMA therapy in PTSD treatment has disappointed psychedelic therapy advocates and has also had an impact on the stock prices of the psychedelic industry leader.
However, it is important to note that the FDA did provide recommendations on how the application could be improved in order for MDMA to potentially receive approval in the future. Despite this setback, the FDA’s decision may not be the end of the road for MDMA-assisted therapy in the treatment of PTSD.
A further setback occurred when the journal Psychopharmacology retracted three papers related to MDMA-assisted therapy, citing “protocol violations amounting to unethical conduct” in one clinical trial. This development has raised additional questions about the integrity of the research surrounding MDMA therapy for PTSD.
In light of these recent events, it is essential to consider the implications of the FDA’s decision on the future of psychedelic medications and the potential impact on other psychedelic drugs seeking approval.
### What is MDMA and What Types of Conditions Could It Treat?
MDMA, also known as midomafetamine, is colloquially referred to as “molly” or “ecstasy.” While technically classified as an amphetamine, MDMA is often categorized as a psychedelic due to its unique effects on mood and perception. It is considered to be more pleasure-inducing than other amphetamines, making it a popular recreational drug in certain settings.
Researchers have described MDMA as an “empathogen” or a “feeling enhancer,” highlighting its ability to enhance emotional experiences. Despite its current classification as a Schedule I drug by the Drug Enforcement Administration, indicating high potential for abuse and no accepted medical use, MDMA has shown promise in clinical trials for the treatment of PTSD.
PTSD affects millions of individuals annually in the United States, with limited treatment options available. Several clinical trials have demonstrated the potential benefits of using MDMA in combination with talk therapy to help patients suffering from PTSD. In recognition of this potential, the FDA granted “breakthrough therapy” status to MDMA-assisted therapy in 2017, expediting its development and review process.
While the FDA’s recent decision to deny approval for MDMA therapy in PTSD treatment is a setback for the field of psychedelic drug development, it is important to consider the broader implications for other psychedelic medications seeking approval.
### Why Did the FDA Decline Approval of Lykos’ MDMA-Assisted Therapy?
In June 2024, an FDA advisory committee voted against the efficacy of MDMA for the treatment of PTSD, as well as against the idea that the benefits outweighed the risks associated with the drug. The committee raised concerns about several aspects of Lykos’ application, including the issue of “functional unblinding” in clinical trials, where participants were aware of whether they were receiving the active substance or a placebo, potentially biasing the results.
Furthermore, questions were raised about the form of psychotherapy used alongside MDMA and ethical concerns regarding misconduct in Lykos’ trials, including reports of sexual misconduct by therapists involved in one study. These issues highlighted the need for rigorous standards in conducting clinical trials for psychedelic medications, particularly those involving vulnerable populations such as individuals with PTSD.
The FDA’s decision to decline approval for Lykos’ MDMA-assisted therapy underscores the challenges and complexities of developing and evaluating psychedelic treatments for mental health conditions. While the decision may be disappointing for advocates of psychedelic therapy, it also serves as a reminder of the importance of maintaining ethical standards and rigorous scientific practices in drug development.
### What Does the FDA’s Decision Mean for the Future of MDMA?
Following the FDA’s decision, Lykos announced its intention to request a reconsideration of the decision and to discuss the agency’s recommendations for improving the application. The FDA requested an additional phase 3 study to demonstrate the safety and efficacy of the treatment in comparison to standard therapy.
Lykos CEO Amy Emerson expressed disappointment in the decision and acknowledged that conducting a new trial could take several years. The retraction of papers related to MDMA-assisted therapy further complicates the path forward for Lykos and highlights the challenges faced by companies in the psychedelic drug development space.
Despite these setbacks, there are other companies in the psychedelic industry that are moving forward with their own drug development efforts. Compass Pathways, in particular, is considered next in line for FDA approval of a psychedelic drug, with phase 3 clinical trials for its synthetic psilocybin underway. These companies are taking different approaches to drug development, which may influence their success in gaining FDA approval.
### Do Psychedelics Face Unique Challenges?
The FDA’s decision regarding Lykos’ MDMA-assisted therapy sheds light on some of the unique challenges faced by companies in the psychedelic drug development space. The nature of psychedelic drugs, which induce altered states of consciousness, presents ethical and practical considerations in conducting clinical trials.
Some individuals in the industry believe that accusations of misconduct are nearly unavoidable given the nature of psychedelic experiences and the vulnerability of participants. Additionally, the pairing of psychedelic drugs with psychotherapy adds another layer of complexity to the drug development process, as the FDA is primarily concerned with assessing the safety and efficacy of the drug itself.
While the FDA’s decision may have implications for the future of MDMA and other psychedelic medications seeking approval, it also underscores the need for rigorous scientific standards and ethical practices in the field of psychedelic drug development. Companies in this space must navigate these challenges to ensure the safety and efficacy of their treatments for individuals suffering from mental health conditions like PTSD.
In conclusion, the FDA’s decision to deny approval for MDMA therapy in the treatment of PTSD represents a significant development in the field of psychedelic drug development. While this decision poses challenges for companies like Lykos Therapeutics, it also highlights the need for continued research and ethical practices in the development of psychedelic medications. As the industry continues to evolve, it is essential to maintain high standards of scientific rigor and ethical conduct to ensure the safety and efficacy of psychedelic treatments for individuals in need.