Part one of a three-part series.
Currently in the form of a pill, the compound was conceived by Vancouver, BC-based natural drug development company Filament Health FLHLF.
During the development process, questions arose:
- What exactly constitutes a dose when discussing a drug typically used within religious contexts?
- What's the need of the drug-induced trip experience (and the typical pre-trip nausea) for obtaining health benefits?
- How can Filament actually perform drug development tasks in a responsible manner facing ayahuasca’s sacramental essence?
Timing does seem appropriate, as psychedelics are becoming more of a conversation topic, and development of a standardized version of ayahuasca is at an early stage.
Filament is trying to get FDA approval to begin the first Phase 1 clinical trial testing the novel drug, hopefully within the first half of 2023.
'Ayahuasca Is Our Roadmap'
“When we set out to start the company, our plan was to work on all controlled substances that are ‘natural’ psychedelics," Filament founder and CEO Benjamin Lightburn — an expert in all things pharmabotanica — told Benzinga.
"Up until now nobody had made natural versions of them, to a degree that they were standardized enough in order to do clinical studies," he explained. "Without clinical studies, it’s impossible to get good evidence for the safety and efficacy for the substances, because if everyone in the study is getting a highly variable, different product, then it’s really hard to draw good scientific or robust conclusions."
Filament’s first drug candidates were all extracted from magic mushrooms’ species and are currently being tested in clinical studies. Now, the Vancouver-based company is working on several different projects simultaneously.
“But ayahuasca was always on our roadmap,” Lightburn said.
Most of the ayahuasca experiences are already natural, as traditional communities directly administer the natural extract.
The issue of extreme variability is present when ayahuasca is administered in a traditional setting: “The amounts of plants that are extracted, the different species that are used, the strength of the extract… Different people in the same ceremony receive a highly variable amount of the psychoactive substances,” Lightburn explained.
Yet, many people report that ayahuasca is greatly helping them with different mental health conditions like PTSD, substance use or just general well-being. Among the rich and famous tuning in to this new trend are:
- Green Bay Packers quarterback Aaron Rodgers, who cited countless manifestos towards psychedelics’ use.
- Will Smith’s “surrendering” experience
- Miley Cyrus’ drug preferences combined with veganism
The key to solidifing the evidence that ayahuasca is helping people, Lightburn says, a standardized product in a controlled setting is needed. That way, scientific conclusions about its safety and efficacy can be made.
Filament’s founder also added that there’s actually been a lot of studies done on ayahuasca already. Dennis Mckenna, a doctor who has been studying ayahuasca for more than forty years, “actually drew a whole lab into the jungle and analyzed the samples of the ayahuasca that was given to the people in the ceremony and then he actually analyzed their blood in the jungle,” Lightburn says.
The company then sees the development of a standard ayahuasca product as “the next logical progression,” in order to draw more conclusions on the drug’s profile.
Filament is now starting clinical trial applications testing ayahuasca and working with UCSF, where the partnership is currently running another psilocybin and psilocin clinical trials.
“It obviously takes a lot of work and preparation to get a clinical trial up and running, especially when it’s for a product that has never been administered in humans before in clinical trials," Lightburn says.
Photo courtesy of Filament Health.
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