While the FDA’s August decision not to approve an MDMA-based treatment for post-traumatic stress disorder (PTSD) was a blow to the larger psychedelic medicine industry and its supporters, all hope is not lost.
Speaking on an October 22 panel at the HLTH conference in Las Vegas, Shereef Elnahal, the undersecretary for health at the Department of Veterans Affairs (VA), and Arizona Senator Kyrsten Sinema outlined steps the government is taking to bring psychedelic medicine into the mainstream healthcare system.
The VA has supported and funded studies for psychedelic therapies and their potential effectiveness in treating PTSD among veterans, roughly 6,000 of whom die from suicide annually. Before the FDA rejected Lykos’s MDMA treatment in August, 80 members of Congress had sent letters to President Joe Biden, FDA Commissioner Robert Califf, and other top government officials urging them to approve the therapy.
“Veterans have been telling me since day one of my job that this potential line of therapy is game-changing,” Elnahal said at HLTH.
While the FDA didn’t heed the call from Congress at the time, Lykos said in an October 18 statement that the company had reached an agreement with the agency on a path forward, which includes completing another Phase 3 clinical trial.
Potential pathways forward
The VA is conducting research that is “well poised” to answer some of the questions the FDA raised when reviewing Lykos’s application, Elnahal said.
For instance, one issue was the “functional unblinding” of the Lykos clinical trial, meaning participants were often able to guess when they were given a placebo.
According to Elnahal, the VA is funding a study in Rhode Island to see how effective MDMA could be in treating veterans with comorbid alcohol use disorder and PTSD. For the placebo arm of the study, researchers plan to give participants a low dose of MDMA to compare its effects against the medication’s full dosage, Elnahal said.
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Another concern the FDA raised was a reported instance of sexual assault that took place during a Phase 2 trial of Lykos’s MDMA therapy. Elnahal said the VA is looking into funding studies in group therapy or other contexts that could help reduce the risk of misconduct.
The VA plans to announce more clinical trials surrounding psychedelic therapies “over the next several months,” Elnahal said.
“We’re already starting to plug some of the gaps that the FDA identified to make the science better and try to accelerate, as much as possible, more veterans getting this new line of therapy,” Elnahal said.
The state-level approach
States are also making progress in clinical research to advance psychedelic medicines, Sinema said, noting that Arizona set aside $5 million this year for research on psilocybin therapy.
“It’s our job to figure out how do we help this nascent work that’s happening in states, and how do we help partner it with those who are doing excellent clinical work, like the VA, so we have top-notch research, top-notch trials that allow us to put the very, very best data in front of the FDA to get approval as quickly as possible,” she said.
Congress hopes to pass legislation by the end of the year that would require the VA to do longitudinal studies to see how long the effects of psychedelic therapies last, Sinema added.
However, some questions remain, including how the FDA will go about regulating a drug that is used as an adjunct to therapy, and how—if approved—health plans would cover psychedelic medicines.
“I do think it’s really important that we continue to [take] a path that allows us to get toward FDA approval, because only through FDA approval can we ultimately make these medicines widely available around the country in a safe manner, not just for veterans and folks who are suffering from PTSD,” Sinema said.