Tetra Bio-Pharma Inc. (OTCMKTS:TBPMF) has provided an update on its CAUM™, ARDS-003, QIXLEEF™, and PPP-003 programs. The company has also announced the filing of the New Drug Submission (NDS) for Dronabinol Soft Gel capsules with Health Canada. Once the agency approves the application, it will give the company its first Drug Identification Number for a THC-based prescription drug, REDUVO™.
Tetra Bio-Pharma awaiting REDUVO™ approval
REDUVO™ which is pending approval from Health Canada will allow the company to establish a revenue stream based on a TC-drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV). By 2022, the addressable market will be approximately CD$80 million. Notably, REDUVO™ will be useful in AID-related anorexia that results from severe nausea and weight loss and cancer chemotherapy-related vomiting.
The company’s CEO and CRO, Guy Chamberland said that they are delighted to have cleared such a massive regulatory milestone with Health Canada. He said that this brings the NDS closer to marketing authorization. As Tetra awaits regulatory approval it anticipates launching REDUVO™ in the second half of 2021. Since the company has attained this massive milestone, it will now accelerate the PPP-002 505(b)(2) program.
Tetra Bio-Pharma offers program updates
On the updates of the programs, the company announced in June 2020 that it had completed the mapping of cannabinoid metabolites, which has a major impact on CUAMZ™ and QIXLEEF™. It also initiated Reborn© study with CAUMZ™ and finalized commercial readiness for CAUMZ™’s manufacturing scale-up. Reborn© study has been designed to show inhaled cannabinoids’ ability to reduce opioid use in patients to manage pain and Tetra will prioritize it over Serenity©.
Equally the company targets completion of toxicology studies necessary to initiate the IND/CTA process for Phase 1 clinical study and develop ARDS-003. Tetra also initiated the QIXLEEF drug supply and study. In August the company announced that it planned to submit Plenitude II© clinical study as a third phase to commence the study in Malta. So far, the company has initiated site and principal investigator selection as the implementation of tetra bio-Pharma Europe continues.