In 2019, the United States FDA identified psilocybin, which is a psychoactive element in psychedelic mushrooms, as a breakthrough therapy. This means that enough evidence has been provided that indicates that a new treatment may be far more effective than the current treatments available. It also means that clinical trials can now be advanced into the drug testing phase. Companies who have been researching psilocybin would do well to grab this opportunity.
In this case, psilocybin-assisted therapy has been used as therapy for MDD, short for Major Depressive Disorder and shows promise, in comparison to results using antidepressants.
While many companies look into various avenues of treatments using psilocybin, some have gone an extra mile to include various drug delivery methods in their clinical trials. While existing studies focus on oils and oral treatments, Cybin Corp. is carrying out trials using dissolvable films that can be likened to minty breath strips. The company has collaborated with IntelGenx, a pharmaceutical manufacturer, to create the films, which may be cherry flavored.
These dissolvable films can be used to deliver the drug directly into the bloodstream when they are placed under an individual’s tongue. This method is more effective, as compared to the gastrointestinal system and liver route taken when an individual swallows a pill. Using other medications as the foundation, they discovered that dissolvable films required a lower dose for a much stronger effect and also had an effect on an individual sooner.
In the clinical trials, a 25 mg psilocybin pill is used as the therapeutic dosage and was recorded to be effective in helping to treat major depressive disorder.
However, the dosage and results of these appear inconclusive as testing and research is still underway to find out the number of milligrams a dissolvable film would require to work just as effectively as a 25mg pill. Researchers speculate it to be between 1 and 7 milligrams, with a top scientist stating that a 3mg dose would be effective but that is yet to be proven.
To test these though, safety needs to be the top most priority, followed by effectiveness. With those cleared, the researchers can now focus on its effectiveness in every individual. This is done by administering different doses on the films in the clinical trial.
The main reason why only a lower dose is administered is because once the film is placed under the tongue, the drug is absorbed directly into the bloodstream then transported directly to the brain. Additionally, the use of oral films in drug administration increases its bioavailability to 100%.
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