The US Food and Drug Administration has denied approval of MDMA-assisted therapy for post-traumatic stress disorder despite overwhelming evidence of the safety and efficacy of this treatment. The FDA requested another Phase 3 trial of the treatment.
“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Amy Emerson, CEO of Lykos, the drug development public benefit company developing the therapy.
You can read more about the FDA’s criticism of the trials and Lykos’ response here and here.
“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson said.
From The Hill:
The decision generated an enormous amount of lobbying from advocacy groups, including combat veterans. Earlier this week, a bipartisan group of more than 80 House and Senate lawmakers sent letters to FDA and the White House urging the approval.
The FDA has not approved any new treatments for PTSD in more than two decades, and proponents have said continued high rates of veteran suicides mean the government must do more to protect veterans.
A growing body of research has shown that psychedelics like LSD, psilocybin mushrooms and MDMA can have significant positive impacts on conditions like PTSD.
Lykos Therapeutics was incubated by the Multidisciplinary Association for Psychedelic Studies (MAPS), the research and educational nonprofit founded in 1986 “to develop medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.” Support MAPS here.
Previously:
• MDMA dose alters white supremacist’s radical beliefs
• Scientists gave octopi MDMA, the results were ‘unbelievable’
• MDMA can help treat PTSD, yet another study shows