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Tetra Bio-Pharma says New Drug Submission for its Dronabinol Soft Gel capsules, has been filed with Health Canada

Published: 14:05 30 Dec 2020 GMT

Tetra Bio-Pharma -
The new drug name, REDUVO, is pending approval by Health Canada

Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development has announced that the New Drug Submission (NDS) for its Dronabinol Soft Gel capsules, has been filed with Health Canada. 

If successful, it will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. The new drug name, REDUVO, is pending approval by Health Canada.

READ: Tetra Bio-Pharma poised to receive government funding to help develop potential coronavirus treatment ARDS-003

REDUVO will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV). The addressable market is estimated to be C$80 million by 20221. It will be indicated in AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy.

In a statement, Dr Guy Chamberland, CEO and CRO of Tetra commented: "We are pleased to have cleared this important regulatory milestone with Health Canada, bringing the NDS one step closer to a marketing authorization. Pending regulatory approval, Tetra anticipates launching REDUVO in the second half of 2021. Now that this important milestone has been achieved, we will expedite the PPP-002 505(b)(2) program."

Tetra Bio-Pharma is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.

Its evidence-based scientific approach has enabled the group to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology.

Contact the author at jon.hopkins@proactiveinvestors.com

 

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