Avicanna Inc (TSX:AVCN, OTCQX:AVCNF) has announced that it will be initiating an observational real-world evidence study using RHO Phyto-branded cannabigerol (CBG) transdermal gel on patients with musculoskeletal pain and inflammation together with Santé Cannabis.
Avicanna said the study will be conducted by Santé Cannabis, an independent clinical research site (CRS) and contract research organization (CRO). It said Santé Cannabis has developed a data collection platform and centred model in executing its role as a CRS and CRO.
“We are happy to partner with Santé Cannabis, which has built a comprehensive registry database for conducting real-world evidence studies,” Avicanna vice president of Scientific and Medical Affairs Dr Karolina Urban said in a statement.
“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.”
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Avicanna said 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 three-month study including clinical visits at baseline and a three-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 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," said 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.”
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 the area of focus. It utilizes Avicanna’s deep-tissue emulsion technology and combines cannabinoids with synergistic natural ingredients and terpenes including menthol, eugenol and beta-caryophyllene.
The prospective study is expected to launch early in the first quarter of 2023.
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.
Contact the author at stephen.gunnion@proactiveinvestors.com