MDMA-AT: We Welcome The FDA to Phase 3 Camp At Burning Man!

A somewhat desperate invitation.

Not to be a know-it-all, but ok. I knew it:

“If they just rubber stamp things and someone dies, or something awful happens, someone is going to come back and make a documentary on Netflix like they did about Perdue Pharma and highlight the FDA official who signed off on the thing after some dubious party. Your whole job, working at FDA, is to ensure you aren’t looking like that gentleman.”

—Owen Scott Muir, M.D., on the Psychiatry Tomorrow Podcast, August 1st.

Just in case you're one of the people who has yet to text me, yes, I heard about the FDA-decision related to MDMA-AT, a New Drug Application submitted to FDA by Lykos Therapeutics.

Point one: we don’t get to see that letter to the study sponsor yet. We do know a CRL, short for “complete response letter” is a hard stop with regards to a current submission:

A complete response letter (CRL) is a notice issued by the Food and Drug Administration (FDA) indicating that an application will not be approved in its present form.

Lykos has responded, sounding like a drug company:

The FDA communicated that it had completed its review of the NDA and determined that it could not be approved based on data submitted to date. The FDA has requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of midomafetamine. Lykos plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.

And to be clear, these determinations have been appealed before:

During the time period from 2003 to 2014, “[o]f the 140 unique appeals accepted and reviewed [131 of which were in OND], CDER granted 23 (16%) appeals and denied 117 (84%).” 

CDER is the Center for Drug Evaluation and Research. In one of the prior cases in which the drug was indicated for a life-threatening condition, the request for more phase 3 data was defeated, and the drug was eventually approved without it. However, that is not an excellent predicate—they called an advisory committee as a response, and the AdComm recommended approval. That, of course, has already happened here, but opposite.

It costs a lot of money to run phase 3 trials, as I’ve previously covered. So, an appeal makes sense…no matter how doomed to failure. However, some parts of the Lykos response seem a bit less…composed, and problematically, factually inaccurate:

"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, Chief Executive Officer of Lykos Therapeutics. Now, I don’t work at the FDA, but a casual observer will note the FDA has, in fact, approved several new treatments for PTSD just recently:

GreyMatters Health received a 510k Clearance for the PRISM system in 2023, which would be one such predicate. On April 10th, 2024, Otsuka and Lundbeck submitted data on their combination product to treat PTSD. In fairness, there is a lot more enforcement action against PTSD grift, however…

It is both factually inaccurate and insulting to the humans who work at the agency to suggest that to request more data on the safety and efficacy of a single submission is to deny all hope to sufferers, especially when that claim is demonstrably false.

The following statement also, in my opinion, went a little far:

Emerson added, "Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options. We intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward for patients who deserve access to midomafetamine-assisted therapy for PTSD."

Or, we could follow my plan. It requires fewer lawyers, and will be way more fun.

I'm proud to announce the opening of a new Burning Man camp. It's called Phase 3 Camp, and it features the quirkiest art cars!