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.
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