Mycotopia Therapies Inc. (OTC Pink: TPIA) has entered into an agreement to form a 50/50 joint venture with Agile Pharmaceutical Solutions to develop novel oral dosage forms of psilocybin in the form of a psychedelic sublingual tablet. Mycotopia said that the two companies plan to get a Health Canada License for psychedelics to obtain and test psychedelic raw material, for the purpose of creating the psilocybin-based, sublingual tablet to take to market.
Mycotopia Therapies and Agile Pharmaceutical Solutions said they plan to conduct oversight and development of the tablet in Jamaica and explore the possibility of partnering with Havn Life Sciences (CSE: HAVN) (OTC Pink: HAVLF) in Jamaica for raw materials and developing the tablet. In August Mycotopia Therapies, Inc. reported that it had entered into a Psilocybin Supply Agreement with Havn Life Sciences to purchase naturally-derived psilocybin.
Ben Kaplan, CEO of Mycotopia Therapies said, “This opportunity to develop a psychedelic sublingual tablet using the intellectual property of Agile Pharmaceutical Solutions is a tremendous opportunity for Mycotopia Therapies. The real opportunity, however, is derived from our two companies working together toward the common goal of revolutionizing how mental illness is treated. The sublingual administration presents an opportunity to possibly set a new standard for psychedelic assisted therapy.”
In October 2018, the Food and Drug Administration granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorders. The breakthrough designation allows for an accelerated pathway to approval. Currently, psilocybin is classified as a Schedule I drug in the US as it has not been approved by the FDA for any therapeutic use. According to the National Institute of Mental Health an estimated 19.4 million adults in the United States had at least one major depressive episode. This number represented 7.8% of all U.S. adults. Recent statistics from the World Health Organization show 3.8% of the world’s population, approximately 280 million people, have depression. At its worst, depression can lead to suicide. Over 700 000 people die due to suicide every year. Suicide is the fourth leading cause of death in 15-29-year-olds.