Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) said that Health Canada has accepted its New Drug Submission (NDS) for REDUVO and has formally entered the final phase in the drug review process.
If successful, the company said REDUVO will be issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN), which permits Tetra to market the drug in Canada and indicates the drug's official approval in Canada.
REDUVO is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection.
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The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.
"There is a need for alternative therapies for patients experiencing CINV, who don't respond well to the conventional drugs used to control nausea and vomiting,” said CEO Dr Guy Chamberland in a statement.
“Prevention of CINV remains a priority to reduce further illness in patients receiving chemotherapy. Tetra anticipates that REDUVO will be publicly and privately reimbursed by provinces and Canadian private healthcare plans. We will continue to work closely with Health Canada as we seek to bring this therapy to patients as soon as possible."
Tetra noted that chemotherapy-induced nausea and vomiting is one of the most common side effects of chemotherapy treatment. Some studies indicate that untreated CINV can affect up to 70% to 80% of all people undergoing chemotherapy. Patients who poorly manage CINV may have a decreased quality of life.
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