FDA deadline on ecstasy for PTSD prompts lobbying blitz

• The current focus is on post-traumatic stress disorder, which affects about 13 million people in the U.S. and hasn't seen a new treatment approved in more than two decades.
• PTSD is of particular concern for veterans. Almost 6,400 veterans died by suicide in 2021, according the most recent available data from the Department of Veterans Affairs.

State of play: The FDA faces an Aug. 11 deadline for deciding whether to give Lykos Therapeutics the green light for a post-traumatic stress disorder treatment that combines talk therapy with the drug commonly known as ecstasy or MDMA.

• An FDA advisory panel in June overwhelmingly recommended against approving the treatment, citing missing safety data, allegations of misconduct in clinical trials, and difficulty teasing apart how much of the reported benefits stem from the drug versus the accompanying psychotherapy.
• The agency could approve Lykos' application outright or ask the company to make changes and and resubmit the application.

The latest: Congress has joined the fray. More than 60 members of the House of Representatives and 19 senators in letters this week highlighted the potential promise of MDMA-assisted therapy and urged the FDA to follow the science.

• Many veterans and other advocates believe the science behind MDMA-assisted therapy is sound. Healing Breakthrough, a nonprofit dedicated to advancing MDMA-assisted therapy to help veterans, took veterans to more than 50 meetings with legislative offices since early June, said Juliana Mercer, the group's veteran advocacy and public policy director.
• "It's a moral imperative that this solution be available to not just veterans who are losing their lives here on American soil at an alarming rate, but to everybody that is suffering from post-traumatic stress disorder," Mercer, a U.S. Marine Corps veteran, told Axios.
• Some prominent mental health experts and billionaires have pushed FDA to approve of the therapy, too.

The other side: A vocal contingency of opponents say approving Lykos' application would do more harm than good.

• "When we're talking about regulation for medicine that is being pitched to the most vulnerable, multiply traumatized demographics in society, the standards should be high to get this right before it's scaled," said Neşe Devenot, a board member at Psymposia, a psychedelic science and harm reduction nonprofit that's led opposition to Lykos' application.
• Some MDMA therapy trial participants felt pressure to report positive outcomes despite worsening thoughts of suicide and other adverse effects during treatment, the Wall Street Journal reported on Monday.

What they're saying: Lykos chief communication officer E. Blair Clark-Schoeb says the company designed its study in conjunction with the FDA and has convened an independent advisory board to help incorporate the treatment into the health system if it's approved.

Between the lines: The FDA typically takes its advisory panel's recommendation on drug approvals, but public pressure can affect the agency's decisions, Aaron Kesselheim, a professor at Harvard Medical School, told NPR.

• The FDA approved Biogen's controversial Alzheimer's drug, Aduhelm, in 2021 after advisers recommended the agency not approve the medication. Biogen took the drug off the market early this year.

What to watch: An LSD treatment for generalized anxiety disorder and psychedelic mushroom-assisted therapy for treatment-resistant depression are also making their way through the FDA's regulatory apparatus.