Avicanna Announces Completion of Topical Gel Observational Real-World Evidence Study

TORONTO, April 10, 2024 (GLOBE NEWSWIRE) -- Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the completion of its observational real-world evidence ("RWE") study using RHO Phyto branded cannabigerol ("CBG") transdermal gel on patients with musculoskeletal pain and inflammation.

The RWE study evaluated patient-reported efficacy of the RHO Phyto CBG Transdermal Gel containing 2% cannabidiol ("CBD") and 1% CBG on a range of clinical conditions including arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, muscle and joint pain, localized pain, muscular and structural injuries, and post-surgical pain. Seventy-one participants completed baseline testing and a follow up at one month including demographic, medical history, medication use and two standardized symptom questionnaires.

The RWE study revealed a meaningful improvement in overall Musculoskeletal Health Questionnaire scores (p<0.001) as compared from baseline to one month. Specifically, there was a reported 35.4% improvement in health-related domains including symptoms, physical functioning, daily activities and work, physical well-being, and confidence to manage symptoms. In addition, evaluation of the Edmonton Symptom Assessment System questionnaire also revealed an improvement in pain, sleep, anxiety, and well-being symptoms from baseline to one month (p<0.001).

"The preliminary result of this study is in line with the reported results of our products with Canadian patients providing valuable insight for our next stages of clinical development. In parallel, this will propel our efforts under medical cannabis or cosmetic legislation internationally," stated Dr. Karolina Urban, Executive Vice President Medical Affairs.

The RWE study participants with an average age of 58 ± 15 (64% women) all presented with symptoms of chronic pain. According to ICD-10 diagnosis classification, 21.1% of participants had a diagnosis related to arthritis (polyarthritis, osteoarthritis, etc.), 17.5% of participants with a diagnosis of dorsalgia, 12.3% with fibromyalgia, and 8% with chronic intractable pain. Prior to initiation of the study, study participants reported they were taking an average of ten medications including NSAIDs, opioids, antidepressants, or skeletal muscle relaxants. Each RWE study participant was assigned a common treatment plan of a combination of a CBD oil (83.3%) or balance oil (16.7%) with the RHO Phyto CBG Transdermal Gel.

About the 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 Avicanna Inc. 

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development leading to the commercialization of more than thirty proprietary, evidence-based finished products and supporting four commercial-stage business pillars.

• Medical Cannabis formulary (RHO Phytotm): The formulary offers a diverse range of proprietary products including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids, supported by ongoing patient, and medical community education. RHO Phyto is an established leading medical brand in Canada currently available nationwide to patients across several medical channels and continues to expand into new international markets.

• Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients' needs and enhance the patient journey. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.

• Pharmaceutical products (Truneroxtm) and pipeline: Leveraging Avicanna's scientific platform, vertical integration, and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific pharmaceutical products that are in various stages of clinical development and commercialization. These cannabinoid-based drug candidates aim to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna's first indication-specific pharmaceutical drug, Truneroxtm, was approved Q1 2024 by the Health Authority of Colombia INVIMA as an adjuvant treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.

• Active pharmaceutical ingredients (Aureus Santa Martatm): Active pharmaceutical ingredients ("API") supplied by the Company's majority owned subsidiary Santa Marta Golden Hemp SAS ("SMGH") is a commercial-stage business dedicated to providing a various forms high-quality CBD, THC and CBG to the Company's international partners for use in the development and production of food, cosmetics, medical, and pharmaceutical products. The business unit also forms part of the Company's supply chain and is a source of reliable input products for its consumer retail, medical cannabis, and pharmaceutical products for globally.
  

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 using words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe", "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions. 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 April 1, 2024 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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