Early Healthcare Forum Takeaways, FDA’s Ibogaine Blueprint, and Compass Talks Pricing

Welcome to the Psychedelic News Feed, a podcast from Psychedelic Alpha. Each episode brings you up to speed with the latest across psychedelic drug development, policy, and access from around the world. It's presented by me, Josh Hardman, Psychedelic Alpha's founder and editor. These are intended to be concise summaries as opposed to deep dives. If you are looking for more nuanced analysis, exclusive interviews and unrivaled reporting on these topics and much more, head to psychedelicalpha.com.

Welcome to the third episode of the Psychedelic News Feed podcast. This episode covers October fifth to eighteenth twenty twenty six. We have five main stories to run through today and then some additional headlines. The first is some early notes from the Psychedelic Healthcare Forum that we hosted last week in New York City. The second looks at a preliminary ibogaine trial design floated by FDA, which has also asked for input on the topic.

We then look at Compass Pathways, which is talking pricing of its psilocybin candidate, potential labeling, and its plans for a relatively slow rollout. We then look at New Mexico, which is nearing the launch of its medical psilocybin system. And lastly, we look at six potential psychedelic brand names, at least according to trademark filings, before getting into some other headlines. So let's get into it. This episode of the Psychedelic News Feed is supported by UBC.

As psychedelic therapies move toward potential approvals, UBC helps sponsors navigate the evidence generation, pharmacovigilance, and comprehensive risk management strategies that support a path forward grounded in patient safety. Learn more at ubc.com. Last Thursday, we co-hosted the Psychedelic Healthcare Forum at the New York Academy of Medicine together with Horizons, which has been running its psychedelic conference for nineteen years now. The event saw federal officials, investors, drug developers, care delivery experts, and others share their perspectives on the field as we approach what could be the first approvals of psychedelic medicines in the coming months, at least in the United States. For my part, I presented a sort of state of the industry and had two on-stage conversations.

The first was with Matt Zorn, who's a deputy general counsel at the US Department of Health and Human Services, who has been called a psychedelic czar within the department since joining last year. In our on-stage discussion, he emphasized that the executive order signed in April elevates psychedelic initiatives across his department and enables agencies to prepare for the potential rollout of psychedelics before approvals, but it doesn't change statutory or regulatory standards, he also emphasized. He also drew attention to the various public engagement initiatives that the department has embarked on, including public comment periods, FDA's public hearing, and requests for information. Interestingly, he did cast some doubt on whether state-regulated models of psychedelic access like those seen in Oregon and Colorado will survive in the long term. And he also said that we need to start looking at safety and adverse events carefully and that use outside of medical channels could result in adverse events.

That use could be encouraged potentially by FDA approval, he added. But in other places, Zorn was more guarded or limited in what he could share. For example, he couldn't provide an update on progress in shoring up psychedelic access through the right to try pathway, which was envisaged in the executive order, and he also couldn't discuss the inevitability or not of bifurcated scheduling, which is a scenario whereby the approved drug product is rescheduled, but the underlying substance remains in a higher schedule like schedule one. So no comment there. Later in the day, I spoke with Carole Ho, who heads up Eli Lilly's neuroscience division.

Obviously, Eli Lilly closed its $3,800,000,000 acquisition of AtaiBeckley, the psychedelic drug developer, last month with 2,800,000,000 of that valuation paid upfront. In our discussion, Ho emphasized that Eli Lilly is in it for the long run-in terms of its work in the psychedelics field, and she expressed interest in the full pipeline of AtaiBeckley, not just five m e o DMT. So also its other candidates, which include a DMT-based candidate, but also ibogaine. But there, she did say that the company is mainly interested in ways of improving the profile of ibogaine, perhaps suggesting that they won't be developing more conventional forms of the substance. We also heard from federal officials.

In one panel, we had Andrew Gradison from the VA, Valentina Mantua from FDA, and Al Bugazia from ARPA-H. Gradison announced that the VA has selected 10 sites that have experience with psychedelic research who would constitute the network for an initial rollout within the Veterans Health Administration and that those sites are preparing to deploy psychedelics if approved, though he wouldn't name them just yet. But some might be disappointed in the scale of rollout in the VA, at least in initial years, with Gradison saying it will be a challenge in the first year to treat four digits worth of patients, meaning that we might expect fewer than a thousand patients to be treated in that system in the first year of any rollout. He said that is slower than he would like and that many veterans would like, but emphasized that these will be labor-intensive, resource-intensive interventions. And he said that the agency is pursuing a sort of safety-first approach, and it will collect real-world evidence or real-world data in the process.

Mantua at FDA reiterated something that we've reported on previously, which is that the division of psychiatry is being kept very busy by psychedelic candidates, with a third of its workload dedicated to psychedelic drugs. And, Bugazia at ARPA-H discussed the agency's work in trying to catalyze ibogaine research, but he also emphasized that the types of clinics offering this in Mexico or in retreat settings are often doing things that might be quite difficult to replicate in the US. He cited things like access to nature and community and the sort of group process that participants in these retreats or at these clinics often go through. Instead, he said, in the US, we're thinking of having somebody in a white room on their own. So some caution there.

Bugazia drawing attention to the sort of very different setting that ibogaine could be delivered in, at least in trials in the US system. We're still processing the forum ourselves, but we'll share more detailed takeaways in the coming weeks through psychedelicalpha.com. Elsewhere, earlier this month, the US Food and Drug Administration, FDA, announced a request for information concerning early-stage ibogaine studies. In doing so, it also published a potential trial design for such studies, telegraphing its thinking on key elements that it might expect to see in any investigation on new drug applications, so IND applications. It reminds me of ARPA-H's Proposers Day last month in Washington DC, where the deputy director of FDA's division of psychiatry, Bernard Fisher, told attendees that the agency was thinking about how much information it needs to put out there proactively to inform the field when it comes to ibogaine research.

His comments were well received then, and it appears that the agency has quickly delivered on that intention now with this RFI and this draft IND or trial design. And investigators that I've spoken with since have welcomed the move. Among the elements FDA floats in its hypothetical sort of early-stage study are dose ascending cohorts capped at ten milligram per kilogram. Participants are to be dosed one at a time in an inpatient unit that's equipped for cardiac emergencies with continuous cardiac monitoring that could last as long as thirty-six hours. Participants will be expected to stop certain medications, including opioid agonists and SSRIs.

There would be strict stopping rules that are detailed in the document. Participants would undergo repeated cognitive testing over the space of twelve months, among other trial design features. We expect some comments to push back on parts of that outline, especially the ten milligram per kilogram maximum dose, which some will want to push higher. But the challenge has been getting early-stage trials of ibogaine cleared in the US, and this request for information moves that conversation into a more open forum rather than restricting those conversations to bilateral meetings between sponsors or investigators and the agency. That request for information is now open through November 20.

As it gets closer to a potential approval, Compass Pathways, a psilocybin drug developer, has been sharing more about its launch plans, mostly at investor events over the past month or so. In terms of a progress update, it plans to submit the final parts of its new drug application to FDA this quarter. It said that a draft label and proposed risk evaluation and mitigation strategy are already under review by FDA and that the company submitted its eight factor analysis, which is used to inform scheduling decisions to the agency, and site inspections began last month. In terms of dosing, Compass expects the label to specify a sort of induction dose or an initial period of two doses given no sooner than three weeks apart with subsequent doses of psilocybin administered at the clinician's discretion. So that's what the label could look like.

In terms of pricing, we had been guiding for a long time that we expected Compass to benchmark its pricing against the annualized price of Spravato, given that it's the only approved drug for treatment-resistant depression. That would keep things fairly simple. Indeed, Compass has now sort of confirmed this, putting Spravato's annualized price at around 50 to $65,000 and now confirming that it plans to price its psilocybin product if approved per dose. So if we assume three doses a year, which is the middle of its two- to four-dose expectation, that puts a single dose of psilocybin somewhere around 17 to $22,000. Compass has also been careful to set expectations for the launch itself.

It will encourage sites to start slowly and gain experience before scaling, it says, and it will provide some handholding to make sure that sites are trained and prepared and that reimbursement works. Compass' CEO, Kabir Nath, repeated that message at the STAT Summit in Boston, which ran last week during our Psychedelic Healthcare Forum, saying that the company will go slow before it goes fast and warning that negative early experiences for patients or providers could damage the whole psychedelics field. Interestingly, NASS was a little bit more guarded on pricing in that setting than perhaps Lori Englebert, the chief commercial officer, had been in earlier conversations, but he did describe SPRAVATO as a reference point. While it's likely to price its psilocybin if approved in line with that of SPRAVATO, the company has been stressing recently that it isn't targeting patients who are doing well on SPRAVATO to switch to psilocybin. And it's also been emphasizing its treatment-resistant population, which is sought to distinguish from major depressive disorder populations in other drug developers' trials.

New Mexico's Department of Health held a public rulemaking hearing two weeks ago related to its medical psilocybin program as it gears up for an expected launch to patients by the end of the year, which is a year ahead of its original schedule. The department had received 80 written comments in advance of that hearing, and a further 28 people commented on the day with five minutes apiece to speak. The most impassioned comments centered on access, particularly regarding a provision that would require landlord consent for treatments to take place in a rented home and a sort of thirty-day window that the department intends to give itself to review patient applications. Now those commenters argued that the landlord requirement would force patients to disclose their medical conditions with their landlords, which is a bit maybe shaky given the federal Schedule I status of the drug and argue that this sort of stipulation would fall hardest on those renting, so younger people, but also homebound patients that might be suffering with end-of-life distress. And those working in end of life care also warned that their patients can't afford to wait for thirty days for approval either.

The written comments will be published alongside the department's response in the coming weeks, and that response should include proposed amendments to the draft rules, could reflect some of those comment. We've also been keeping an eye on potential brand names of psychedelic drug products if approved. We've been keeping an eye on this via trademarks, and so far, we'd already reported on a potential MDMA brand name, RYSANSO, which was presumably accidentally included in the slides for the August 2024 advisory committee, which reviewed MDMA for PTSD. Since then, I think in the first episode of this podcast, we actually mentioned it. We've reported that Usona Institute looks set to call it psilocybin product ARUMAYA if approved.

But now since then, we've also come across potential names for Compass Pathways psilocybin product and Definium Therapeutics LSD. Now companies usually file a few for various reasons, including the fact that FDA could reject a proposed brand name. Now these are tricky to say on a podcast given that we don't know how the company expects them to be pronounced. But for Compass Pathways, we have these three potential psilocybin brand names. We have NUFONDIS, IXPLIRA, EMPAQUIST.

And for Definium LSD, we have another three potential names, ADLIZA, NEUPLIXO, and NEUVDI. Now we view it as quite likely that the products will be given one of these handful of names if approved, but it is also possible that there could be other names in the running. We have just a few other headlines for this episode of the Psychedelic News Feed. First up, Blake Mycoskie, who founded Toms Shoes, was the subject of a feature in Forbes Magazine last week. He's now given approximately 18,500,000 of a $100,000,000 philanthropic commitment he pledged to psychedelics back in 2023 according to that article.

But given his own experience, he says he now thinks that therapy preparation and integration matter more than the drug. So his philanthropic focus is going to shift to that side of the sort of care continuum, he says. Elsewhere, we've reported that the National Institute of Mental Health will soon publish a grant opportunity titled Advancing Real World Effective Evidence for Rapid Acting Psychotropic Interventional Drugs, the latter part being referred to as RAPIDs. And that opportunity, once available, could provide up to $20,000,000 in aggregate funding, split between three projects. In Oregon, a mystery shopper-type study found that the state's licensed psilocybin service centers were generally following the state's rules, especially when it came to screening.

So researchers posing as prospective clients got in touch with 15 of the 22 active psilocybin service centers in the state, and none of them said that take-home use would be allowed, for example. Though the authors do highlight that the median session cost was $1,900 and that no center accepted insurance, which continues to raise questions about equitable access in Oregon's system. Another academic publication from the last couple of weeks provides an analysis of the twenty twenty five national survey investigating hallucinogenic trends, which was published in JAMA Network Open, and that found that self reported adverse outcomes were most often associated with ibogaine and five m e o DMT that the study has various limitations, including differences between the type of people who might use each drug, things like poly drug use, and so on. And lastly, a reminder that public comments on the US Drug Enforcement Administration's proposal to place five tryptamine psychedelics in schedule one, which we covered last episode, are due this Friday, October 23. If you want more from Psychedelic Alpha, we published the seventh issue of The Psychedelic Practitioner last week, which focused on preparedness for potential FDA approvals and rollout at the sort of systems level.

So things like reimbursement, setting up standard operating procedures, thinking about the infrastructure required to deliver psychedelics, at least in The US health care system, that we also spoke to people operating in places like Australia. So that's it for our third Psychedelic News Feed. A little bit shorter this time, partly because we're still sort of landing after Thursday's Psychedelic Healthcare Forum and related meetings and gatherings, and we do look forward to sharing more from that conference in due course. But thanks for listening to this episode. Have a great day.

That's it for this edition of the Psychedelic News Feed. For deeper analysis, exclusive interviews, and reporting that you won't find anywhere else, head to psychedelicalpha.com. Have a great day.