(Globe Newswire) Toronto — Avicanna Inc. 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.