The Food and Drug Administration (FDA) on Friday denied approval of an MDMA-based treatment for post-traumatic stress disorder (PTSD), the manufacturer said, a major setback for the use of psychedelic drugs as medicine.
Pharmaceutical company Lykos Therapeutics said the FDA told them the treatment “could not be approved based on the data presented to date”.
Lykos said the FDA has requested an additional Phase 3 trial to further study the treatment’s safety and effectiveness, but these studies often take years. The company said it plans to request a meeting with the FDA to ask for reconsideration.
“The FDA’s request for another study is deeply disappointing, not only to all those who dedicated their lives to this pioneering effort, but most importantly to the millions of Americans with PTSD, along with their loved ones, who did not see any new options of treatment in the world. more than two decades,” Lykos CEO Amy Emerson said in a statement.
The decision was widely expected after an independent FDA advisory panel overwhelmingly recommended approval of the treatment, which combined MDMA, commonly known as ecstasy, with psychotherapy to treat PTSD.
The panel raised questions about the integrity of the trial studying the treatment. In particular, agency staff noted that patients in the trials were able to guess whether they had received MDMA or a placebo, making it virtually impossible to “blind” the study.
They praised the treatment’s promise, but said the risks far outweighed any benefits, and expressed concern that the manufacturer’s scientific work had been influenced by the psychedelic evangelism of its parent organization, the Multidisciplinary Association for Psychedelic Studies. They also questioned whether the company had adequately tracked serious adverse events during trials.
“Although conducting another Phase 3 study would take several years, we still maintain that many of the requests that were 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 aa scientific literature,” said Emerson.
The decision generated enormous lobbying from advocacy groups, including combat veterans. Earlier this week, a bipartisan group of more than 80 House and Senate lawmakers sent letters to the FDA and the White House asking for 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 suicide 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.
The order marked the first time the US considered a Schedule I drug – those considered to have a high potential for abuse, such as heroin and LSD – for medical use.
More than 13 million people in the U.S. live with PTSD, and veterans are disproportionately affected, according to estimates from the National Center on PTSD. But current treatments are notoriously not very effective.
This story originally appeared on thehill.com read the full story
