Tetra Bio-Pharma submits FDA Orphan Drug Designation applications

Orleans-based Tetra Bio-Pharma submits multiple applications of Orphan Drug Designation for cannabinoids to the U.S. Food and Drug Administration (FDA) for various forms of rare cancer and ocular diseases.

The applications align with Tetra’s strategy to develop cannabis prescription drug products for the treatment of several rare cancers and to expand its market exclusivity in the treatment of ocular diseases. If successful, the designation of cannabinoids as an Orphan Drug will open the door for fast track approval, tax credits on clinical research, and reduced registration fees, in addition to other opportunities. It further provides Tetra with a 7-year period of market exclusivity in the U.S.

“Managing rare forms of cancer presents a huge challenge for physicians,” says Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO of Tetra Bio-Pharma. “Our R&D team has submitted numerous Orphan Drug Designation applications to the FDA over the past 6 months, which not only holds promise to improve patient care but lines up with our corporate strategy to develop and commercialize cannabinoid prescription drug products for both rare cancers and ocular diseases in the United States.”

This application builds on previous milestones for Tetra Bio-Pharma in cancer, and pain conditions. In May 2017, Tetra announced its partnership with Panag Pharma to develop innovative cannabinoid-based prescription drugs for the treatment of ocular inflammatory and pain conditions. They also submitted patent applications to expand its exclusivity for the development of pharmaceutical drug formulations to treat various forms of cancer and ocular disease.  This latter protection complements the intellectual property owned by Panag Pharma.

Just this past March 2018, Tetra announced that the U.S. FDA granted an Orphan Drug Designation for Complex Regional Pain Syndrome. The company has expanded its regulatory activities in the USA to accelerate making cannabinoid-based prescription drugs accessible to patients.

Rare cancers present different challenges, and specific drugs need to be made to address this issue. They are harder to diagnose and involve numerous physician visits while the more common causes are being ruled out. Due to the lateness of the diagnosis they are often harder to treat as they have advanced stages. This application may be a step forward in providing treatment to those in need.

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