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Psilocybin Mushroom Nasal Spray

In 2019

Silo established a proof of concept of a psilocybin metered-dose nasal spray in Jamaica.

Bypassing the Gut Entirely

The nasal spray bypasses the digestive system by
entering the bloodstream through the nasal
membranes.

Silo Wellness

July 2019 – Files provisional patent application for psilocybin nasal spray (Provisional Application No. 62/870,722)
December 2019 – Announces the development of psilocybin nasal spray in Jamaica
July 2020 – Files nonprovisional utility patent application for “Metered Dosing Compositions and Methods of Use of Psychedelic Compounds“ of which the psilocybin nasal spray is one product example. Non-provisional International Patent Application Number: PCT/US20/40826 filed pursuant to the Patent Cooperation Treaty

Oregon’s Measure 109 was on the November 2020 election ballot, and was passed by Oregon voters in the election. Oregon becomes the first state in the United States to allow the use of psilocybin in therapy. The measure does not decriminalize psilocybin. It remains a Schedule I drug under federal rules and thus not approved for any medical uses. Instead, Measure 109 directs the Oregon Health Authority to create a state-licensed, psilocybin-assisted therapy program over the next two years and determine how it would regulate the therapeutic use of the ingredient. Ultimately, Measure 109 allows therapists to use psilocybin to treat chronic mental health issues like PTSD and depression. The Oregon Health Authority may permit therapists to incorporate psilocybin for anxiety reduction in terminally ill patients and to assist with addiction cessation. Psilocybin will not be available for purchase in stores. It will only be available through an extensive, three-session therapy system located in state-licensed psilocybin service centres.

Once the regulatory regime for psilocybin-assisted therapy is implemented, Silo Wellness intends to consider offering psilocybin retreats in Oregon as well as pursue a clinical psilocybin-assisted counseling element with patients using the psilocybin nasal spray prior to sessions through either licensees or through Silo Wellness’s own branded psilocybin service centers.

Silo Wellness has developed and finalized of the formulation of a psilocybin nasal spray in Jamaica, where such psychedelic compounds are legal. In addition, Silo Wellness has managed SW Holdings’ IP related to this psilocybin nasal spray via the filing of provisional and non-provisional patent applications in the United States. Although psilocybin and other psychedelics substances are Schedule I controlled substances, there are no legal impediments to patent issuance for Schedule I controlled substances. The ability to patent inventions related to scheduled controlled substances was most evident in the cannabis industry that saw many issued patents following federal prohibition. For example, the United States federal government’s own National Institute on Drug Abuse, the government agency responsible for studying and controlling drug abuse, was granted a patent in 2003 after their discovery that cannabinoids have some legitimate medical uses. See PCT/US99/08769 (Patent No. 6,630,507). An example of a metered-dosing patent in the cannabis space includes the now-expired 2003 issuance to Virginia Commonwealth University for Δ9-tetrahydrocannabinol (Δ9 THC) to be delivered by metered dose inhalers. See US09/273,766 (Patent No. 6,509,005B1) (https://patents.google.com/ patent/ US6509005B1).

From its experience in operating its wellness retreats in Jamaica, the Company has learned from its retreats that the market in Jamaica does not require advanced dosing methods at this time. As a result the Company is continuously monitoring recreational market demand for the nasal spray prior to expending further capital in its development. Additionally, the Company has been in negotiations with other companies with interest in licensing the nasal spray intellectual property. The Company has received feedback from potential licensees with interest in a pharmaceutical use for the nasal spray. Consequently, the Company continues negotiations with other companies regarding licensing arrangements prior to attempting to bring the nasal spray to market in Jamaica.

The Company current focus of attention is its Marley One line of non-psychedelic functional mushroom products and retreats and has not conducted further testing of its patent-pending nasal spray.