The emerging psychedelic pharmaceutical industry was dealt a shock on June 4 after a U.S. Food and Drug Administration advisory panel recommended the rejection of Lykos Therapeutics’ application to have MDMA (methylenedioxymethamphetamine) approved as a prescription medicine to treat post-traumatic stress disorder.
As the first psychedelic medicine to receive the FDA’s “breakthrough status” designation, a designation that may accelerate the adoption of promising treatments, MDMA has the potential to pave the way for a new and powerful niche in mental health pharmaceuticals.
While the federal government might have hit a roadblock in legalizing MDMA for pharmaceutical use, state governments can still move forward in legalizing access to the psychedelic.
Politically, it has been easier for state lawmakers to defer to the FDA to approve new medications. However, it is unclear whether any psychedelic pharmaceutical company can overcome the research methods standards at the FDA and successfully introduce a new drug.
In the case of MDMA, the FDA recognized its unique potential by granting the substance a “breakthrough therapy” designation, and clinical trials generally confirmed the safety and effectiveness of the drug in treating post-traumatic stress disorder. However, progress has been halted by the FDA advisory panel’s reluctance to recommend approval of a psychedelic medicine.
One reason why FDA advisors might be reluctant to move forward on MDMA is due to concerns about the techniques used in the clinical trials. One concern is that a high number of participants can identify when they are in the placebo group, defeating the long-held gold standard of a control group that is “blind” to whether they received the drug. Researchers have attempted different mathematical techniques and survey questions to address issues around blinding and other concerns. When these approaches are applied to clinical trial data, the statistical differences between the placebo and treatment groups become harder to distinguish.
But, even with advancements in research techniques, it might take some time for FDA regulators to fully come around to the idea of MDMA for pharmaceutical use, which makes the federal drug approval pathway difficult and uncertain. However, just as with legalizing cannabis, states can create pathways of their own to enable access to pharmaceutical MDMA.
Oregon and Colorado have already legalized the use of another promising psychedelic, psilocybin, in professional treatments. As the active ingredient in “magic mushrooms,” psilocybin is still federally illegal, and there are ongoing clinical trials of synthetic versions. While legalizing plants, such as cannabis and psychedelic mushrooms, is easier for states because consumers can grow them, it is also possible to legalize the manufacturing of synthetic chemicals, such as MDMA.
For instance, California State Sen. Scott Wiener (D-San Francisco) had originally proposed legalizing MDMA in Senate Bill 1012. The MDMA inclusion was later stripped out of the bill, which ultimately failed to pass. Had it passed with the MDMA component, the bill would have required a state agency to disseminate specific manufacturing practices.
While these are a few examples, states have many options when considering the legalization or decriminalization of psychedelic medicines within their borders. They could choose to allow a company with basic safety and efficacy evidence, such as Lykos’s MDMA compound, exclusive rights to manufacture in the state. Legislators could propose pilot programs similar to those in Japan, where consumers may purchase access to participate in early drug trials that have already passed basic safety standards. Or, states may allow direct sales from multiple manufacturers, as many now do with cannabis products.
To be sure, this is new territory. States have not had to develop comprehensive protocols for therapy paired with synthetic pharmaceuticals. However, Oregon has established a clinical protocol for psilocybin-assisted therapy using products manufactured under exacting state standards. The main difference between this approach and a synthetic medicine like MDMA is that the active compound is derived through a chemical reaction rather than a plant extract.
Regardless, in the wake of the FDA advisory panel’s reaction to MDMA, it now seems clear that the locus of action for psychedelic therapies will be at the state level, just as it has been for medical marijuana.