Avicanna Obtains Its First Indication-Specific Drug Registration with Trunerox™
Approval issued by the Health Authority of Colombia INVIMA for Adjuvant treatment for seizures associated with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS)
TORONTO, Feb. 13, 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 Company’s first indication-specific drug registration for Trunerox™ issued by INVIMA, the Health Authority of Colombia.
“The approval of our first pharmaceutical product is an exceptionally significant milestone and a major step towards our long-term vision as a biopharmaceutical company with the aim to serve patients with unmet medical needs. It is also rewarding to be able to deliver this medication for such a critical medical condition at an accessible price through our vertical,” stated Aras Azadian, CEO.
The Trunerox drug approval (Registro Sanitario como medicamento) was issued by INVIMA, after a detailed process of verification of all legal, technical, and pharmacological requirements were fulfilled in accordance with Decree 677 of 1995 and other applicable regulations. The approval allows Avicanna to manufacture and commercialize Trunerox in Colombia with approved indications and claims associated to the treatment for seizures related to Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS). Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) are two of the various, rare epileptic disorders classified as epileptic encephalopathies.
Trunerox is Avicanna’s proprietary oral formulation with 10% cannabidiol (CBD) and is manufactured with good manufacturing practices GMP at Altea Farmacéutica in Bogota, Colombia utilizing CBD manufactured at the Avicanna’s majority-owned subsidiary Santa Marta Golden Hemp SAS.
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:
- The formulary offers a diverse range of proprietary formulations including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids and is supported with ongoing patient, and medical community education. RHO Phyto has been established as a leading medical brand in Canada and is currently available nationwide to patients across several medical channels and continues to expand into new international markets.
- : Leveraging Avicanna’s scientific platform, vertical integration, and real-world evidence, Avicanna has developed an extensive 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.
About 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 diverse portfolio of products and a pharmacist led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborating with public and private providers for adjudication and reimbursement and educational resources to facilitate the incorporation of medical cannabis into health care regimens.
SOURCE Avicanna Inc.
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