EXCLUSIVE: The Psychedelics Debate Is 'Raging' As Filament Debuts Ayahuasca Pill

Part two of a three-part series.

Previous story: Standardized Ayahuasca Pill Is Officially Here, Feast Yourself With The Exclusive Details & Insights

When it comes to the ayahuasca pill, Filament Health FLHLF CEO Ben Lightburn says the product won’t just be for the pharmaceutical market.

“Maybe the pharma market will be a relatively small portion," he tells Benzinga. "What I’m talking about is places in the world — jurisdictions like, say, the U.S. — where psychedelics are becoming legal outside of a pharma model. Nonetheless, no matter what kind of market, we think that a standardized product will be necessary for certain parts of the eventual population."

Filament is hoping the U.S. Food and Drug Administration (FDA) begins the first Phase 1 clinical trial in the first half of 2023. If and when ayahuasca is approved, will Filament’s model involve psychotherapy, psychological support or any other form of assistance?

Lightburn says: “The debate is raging in the psychedelics industry."

Compass CMPS, for example, says just psychological support is enough as opposed to psychotherapy.

That is, for the moment being, an increase in the connection between the patient and the therapist that did not lead to better outcomes for the patients in Compass’ ongoing psilocybin trials for depression, Lightburn explained.

The level of therapy involved will depend very much on the substance, he adds.

“Obviously, MDMA will require much more interaction and connection between the therapist and the patient, as opposed to, for instance, psilocybin," he adds. "I think for us, it’s probably too early to answer. It will be based on whatever data comes out of the clinical trial,” which would commence once the FDA approves the trial application. It requires testing ayahuasca’s PK profile and most likely several different dosages.

“Our clinical research set at UCSF is, I would say, somewhere in between. It’s not like a minimalist, hands-off approach, but it’s also not an in-depth therapeutic frame. They’re there to provide support and safety and guidance, and it seems to be going okay in that regard. But the overall answer is we need to see with research,” Lightburn says.

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Filament uses a similar extraction process — as compared to psilocybin — to get the target compounds out of the biomass. But the raw material — raw mushrooms vs. vines and leaves — is very different.

“Also, the physical properties of the compounds: DMT is much more stable than psilocybin and psilocin, same with the harmaline and the others, they’re very stable compounds," Lightburn says. "So, while some of the processes are similar, how to physically work with the product is very different."

It differs in the sense that Filament sources the raw materials from all around the world, whereas the mushrooms can simply be grown in-lab.

Regarding potential environmental risks involved in the extraction of ayahuasca’s natural plants, Lightburn assures that there is none. 

“Myself and my colleagues, we’ve been working in botanical extraction for our whole careers, and the deforestation, overharvesting of the different species is something that is of very great concern to us, so we would never extract from Peyote cacti, as an example," he said. "With the popularity of ayahuasca, there is an industry for these kinds. They are semi-cultivated, semi-wild harvested, but they’re not in danger of extinction."

Also, Filament works only with Nagoya-protocol compliant sources, so they can be very confident that the plants are being harvested in a sustainable way.

“Because we want there to be a source of supply for the long-term,” Lightburn says, citing South America as a potential place to grow and source materials.

But, the truth is, Filament’s research is still “at a very, very early stage," he says.

In total, the company has imported about one or two kilograms of plants. 

“We are trying to get as many sources of the raw materials, because we want to get an idea of the variability of the plants’ species across different regions. So still a long way from commercial sales,” he says.

The hopes is to one day provide Filament's standardized ayahuasca pill on retreats. But, he clarifies, they are not trying to create a substitute for the ceremony and the cultural tradition, and engage in respecting the most possible In that regard.

“We do think, and I think logically it does make sense, that the participants have a standardized product where they and the person administering it can know that it’s a consistent dose of the DMT," Lightburn concluded. "I think that could lead to better outcomes for everybody."

Photo courtesy of Filament Health.