[co-author: Dr. Madeline Campbell]
Photo by Paweł Czerwiński on Unsplash
Over 300 million people live with depression worldwide. WHO estimates that almost 800,000 people die annually from suicide. Although antidepressants and counseling can be effective treatments for many individuals, there is still a high need for new and more effective therapies, particularly for those with treatment-resistant depressive disorders.
One new type of treatment currently in clinical research trials is the use of psilocybins, the psychedelic drug found in hallucinogenic mushrooms, in a controlled therapy environment. Psilocybins are a Schedule 1 controlled drug under the FDA in the US and Health Canada, the government agency in Canada that regulates drugs and clinical trials, because of the hallucinogenic properties. That aside, both agencies have approved research of psilocybin-assisted therapy sessions. The US studies typically involve participants taking synthetic psilocybin in a more traditional pill format. However, a new drug delivery device being studied under Health Canada could have an impact on the therapeutic use and efficacy of psilocybin-assisted therapy.
IntelGenx, a leading Canadian drug delivery company that focuses on the development of dissolvable films (similar to those in a Listerine breath strip), collaborated with Cybin Corporation, a Canadian life sciences company, to develop a non-intrusive, orally-dissolvable psilocybin strip for the treatment of depression. This partnership opens the door for IntelGenx’s VersaFilm technology to be used as a non-invasive, easily-administered delivery of psilocybins for the treatment of depression.
The companies tout the multiple benefits of sublingual administration, including its increased rate of absorption and bioavailability and faster onset of action. Conventional tablets have to disintegrate in the stomach and pass through the liver prior to entering the bloodstream. However, the oral strip can allow for direct entry into the bloodstream, avoiding the disadvantages of slow gastrointestinal absorption and first pass metabolism with the liver.
Despite its drug classification, Health Canada recently green-lighted the use of the drug in a handful of terminally ill cancer patients. Due to the restrictions and strict rules that govern the development of schedule 1 drugs, Cybin is planning its clinical trials using the VersaFilm in Jamaica because the regulatory control there is more forgiving.
IntelGenx has also entered a feasibility agreement with another biotech corporation, ATAI Life Sciences, to develop an undisclosed psychedelic film for the treatment of mental health disorders.
Recently in the US, the FDA approved two breakthrough therapies for the use of psilocybin in the treatment of drug-resistant depression. “Breakthrough Therapy” is a label that fast tracks clinical trials. There are several other schedule 1 psychedelics that are also being researched or investigated by the FDA as potential breakthrough therapies with the hope of greatly improving treatment for mental health disorders. We look forward to seeing if or when these treatments get FDA approval because of regulatory and other legal implications that often complicate the process.