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Avicanna received first-indication drug registration with Trunerox™

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Approval by the Colombian Health Authority for INVIMA for the adjuvant treatment of seizures associated with Lennox-Gastau syndrome (LGS) and Dravet syndrome (DS).

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TORONTO, Feb. 13, 2024 (GLOBE NEWSWIRE) — Avicanna Inc.Avicanna” or “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) is pleased to announce the company's first indication drug registration for Trunerox, a biopharmaceutical company focused on the development, manufacture and commercialization of plant-derived cannabinoid-based products. ™ issued by INVIMA, the Colombian public health authority.

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Avicanna Trunerox drug approval cannabia

“The approval of our first pharmaceutical product is a very important milestone and a big step towards our long-term vision as a biopharmaceutical company with the goal of serving patients with unmet medical needs. It is also very exciting to be able to bring this medicine to such a critical medical condition at an affordable price through our vertical,” said Aras Azadian, CEO.

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Trunerox approval (Registro Sanitario como medicamento) was granted by INVIMA after a detailed review process of all legal, technical and pharmacological requirements in accordance with Decree 677 of 1995 and other applicable regulations. The approval allows Avicanna to manufacture and commercialize Trunerox in Colombia for the approved indications and claims related to the treatment of seizures associated with Lennox-Gastau syndrome (LGS) and Dravet syndrome (DS). Lennox-Gastau syndrome (LGS) and Dravet syndrome (DS) are two different, rare epilepsy disorders classified as epileptic encephalopathies.

Trunerox is Avicanna's proprietary oral formulation with 10% cannabidiol (CBD) and CBD manufactured by Santa Marta Golden Hemp SAS, Avicanna's main subsidiary, manufactured under Good Manufacturing Practices (GMP) at Altea Farmacéutica in Bogotá, Colombia.

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Avicanna Inc. about

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

  • Medical cannabis and health products (RHO Phyto™): The formulary offers a diverse range of proprietary formulations, including oral, sublingual, topical and transdermal deliveries with varying ratios of cannabinoids, and is supported by ongoing patient and medical community education. RHO Phyto was established as a leading medical brand in Canada and is currently available to patients across multiple medical channels across the country and continues to expand into new international markets.
  • Pharmaceuticals and pipelines: Using Avicanna's scientific platform, vertical integration and real-world evidence, Avicanna has developed a broad network of indication-specific and patent-pending drug candidates in various stages of clinical development and commercialization. These cannabinoid-based drug candidates seek to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna's first pharmaceutical product (Trunerox™) is in the drug registration stage in South America.

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About MyMedi.ca

MyMedi.ca is a medical cannabis care platform created to better serve the needs of medical cannabis patients and improve the patient journey. MyMedi.ca is operated by Northern Green Canada Inc and offers a diverse portfolio of products and pharmacist-led patient support programs. MyMedi.ca also offers special services to special patient groups, such as veterans, and collaborates with public and private providers for legal and reimbursement and educational resources to facilitate the incorporation of medical cannabis into health care regimens.

SOURCE Avicanna Inc.

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For more information about Avicanna, visit our website, contact Ivana Maric at [email protected] or follow us on social media. LinkedIn, Twitter, Facebook, or Instagram.

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The Company will post updates through Company videos YouTube channel.

Caution Regarding Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information in this news release can be identified by words such as “may,” “will,” “will,” “would,” “may,” “may,” “expect,” “anticipate,” “believe,” “intend.” ”, “plan”, “estimate”, “project”, “estimate”, “estimate” and other similar expressions. Even if the Company believes that the expectations and assumptions based on such forward-looking information are reasonable, forward-looking information should not be unreasonably relied upon because the Company cannot prove that they are correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to various risks and uncertainties that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Such risks and uncertainties include, but are not limited to, current and future market conditions, including, but not limited to, the market price of the Company's common stock and the risk factors disclosed in the Company's Annual Information Form dated March 31, 2023 filed with Securities Canada. regulatory authorities and is 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 intention or obligation to update any forward-looking information, except as a result of new information, future events or results, or as required by applicable securities laws.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/44fa3fd6-5819-4310-8905-2c8c38ee6d1b.


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