Avicanna and Santé Cannabis Initiate Real-World Evidence Study on Musculoskeletal Pain and Inflammation with the RHO Phyto™ CBG Transdermal Gel Topical Product

TORONTO, Dec. 14, 2022 (GLOBE NEWSWIRE) — Avicanna Inc. (“Avicanna” or the “Company”) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN), a commercial stage, international biopharmaceutical company focused on the commercialization of evidence-based, cannabinoid-based products, is pleased to announce that it will be initiating an observational real-world evidence (“RWE”) study using RHO Phyto branded Cannabigerol (“CBG”) transdermal gel on patients with musculoskeletal pain and inflammation together with Santé Cannabis, a clinical research site (“CRS”) and contract research organization (“CRO”).

Observational Real-World Evidence Study

The research study will seek to enroll 100 patients and evaluate patient-reported efficacy of the RHO Phyto CBG Transdermal Gel containing 2% Cannabidiol (“CBD”) and 1% CBG on arthritis including osteoarthritis, rheumatoid arthritis, fibromyalgia, muscle and/or joint pain, localized pain, post-surgical pain, muscular and/or structural injuries. The participants, as identified by the healthcare provider will take part in a 3-month study including clinical visits at baseline and 3-month follow-up assessment. In addition to demographic, medical history, medication use and overall symptom assessment questionnaires, the patients will complete the Musculoskeletal Health Questionnaire, a validated measure of symptoms and quality of life.

The study will be conducted by Santé Cannabis, an independent medical cannabis clinic and research services provider. Santé Cannabis has developed a data collection platform and centred model in executing upon its role as a CRS and CRO. The prospective study is expected to launch in early Q1 2023.

‘’The exploration of novel topical formulations is very exciting to our clinical team as products may provide patients with localized pain relief while avoiding systemic effects and side effects all together’’ states Dr. Michael Dworkind, Medical Director of Santé Cannabis and Associate Professor of McGill University. “We are so pleased to work with Avicanna to assess the effectiveness of their RHO Phyto CBG Transdermal Gel, to shed light on the very understudied field of cannabinoid-based topical products.”

Dr. Karolina Urban, Vice President of Scientific and Medical Affairs stated: “We are happy to partner with Santé Cannabis, which has built a comprehensive registry database for conducting real-world evidence studies. With the initiation of the study, we will further demonstrate our ongoing dedication to researching, developing, and making available evidence-based products to patients and the medical community.”

RHO Phyto Transdermal CBG Gel

The CBG Transdermal Gel is a part of Avicanna’s RHO Phyto formulary of medical products which includes proprietary oral, sublingual, and topical products containing a range of cannabinoids. The gel includes a combination of CBG and CBD in a fast-absorbing, water-based gel intended for application locally to area of focus. The gel utilizes Avicanna’s deep tissue emulsion technology and combines cannabinoids with synergistic natural ingredients and terpenes including menthol, eugenol and beta-caryophyllene.

ABOUT SANTÉ CANNABIS

SANTÉ CANNABIS IS CANADA’S MEDICAL CANNABIS CENTRE OF EXCELLENCE:

An independent medical cannabis clinic and clinical practice leader driving research services and healthcare professional training to improve practical knowledge of cannabis-based medicines. Established in 2014, Santé Cannabis has defined medical cannabis patient care and clinical data collection in Canada within a multidisciplinary, patient-centred model of care.

The team of physicians and nurses at Santé Cannabis has supported more than 16,000 patients referred by 6,000 unique physicians across the province of Quebec, providing an innovative, integrated, community-based consult service for cannabis-based medicines.

Recognized internationally as being at the forefront of medical cannabis, Santé Cannabis aims to share the expertise of its team of innovators, healthcare professionals, researchers and support personnel through collaborative networks to support clinic development and clinical research services from strategy and product development consultation to clinical trial recruitment and real-world data processes.

ABOUT AVICANNA INC.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of evidence-based cannabinoid-based products for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development that has led to the commercialization of more than thirty products across various market segments:

Medical Cannabis & Wellness Products: Marketed under the RHO Phyto™ brand these medical and wellness products are a line of pharmaceutical-grade cannabinoid products containing varying ratios of cannabidiol (“CBD”) and tetrahydrocannabinol (“THC”). The product portfolio contains a full formulary of products including oral, sublingual, topical, and transdermal deliveries that have controlled dosing, enhanced absorption and stability studies supported by pre-clinical data. The formulary is marketed with consumer, patient and medical-community education and training.

Pharmaceutical Pipeline: Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has created a pipeline of patent-pending drug candidates that are indication-specific and in various stages of clinical development and commercialization. These cannabinoid-based drug candidates look to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna’s first pharmaceutical preparation (Trunerox™) is in the drug registration stage in South America.

Click to watch Avicanna’s Corporate Video 2022

SOURCE Avicanna Inc.

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Cautionary Note Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this news release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions. Forward-looking information contained in this news release includes, without limitation, statements related to the Offering, the use of the proceeds of the Offering, the receipt of all approvals of the Toronto Stock Exchange in connection with the Offering, statements with respect to the Company’s future business operations, potential collaborations, the opinions or beliefs of management and future business goals. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company’s annual information form dated March 31, 2022, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com. The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

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