Tetra Bio-Pharma has submitted several Orphan Drug Designation applications to the US Food and Drug Administration. The applications are on behalf of cannabinoids for the treatment of multiple rare forms of cancer and ocular disease. For more detailed information, you can view the source press release here, at Tetra’s website.
About Tetra’s Program
Since May 2017, Tetra has been working in partnership with the organisation Panag Pharma on the development of new cannabinoid-based prescription drugs intended to treat pain conditions and ocular inflammatory conditions. Since then, they have worked on submitting patent applications for the development of investigational drugs for several forms of ocular disease and of cancer. Tetra announced in March this year that the FDA awarded them Orphan Drug Designation in relation to Complex Regional Pain Syndrome. For more detailed information about their activities, you can view their press release here.
About Orphan Drug Designation
The US Food and Drug Administration grants Orphan Drug Designation to drugs that are intended to treat rare conditions. ‘Rare’ is defined as affecting 200,000 people or fewer in the United States. If a drug sponsor is granted Orphan Drug status, the drug becomes eligible for several benefits designed to incentivise the continued development of the drug, such as tax credits for clinical testing, waived prescription drug user fees, and a seven-year period of marketing exclusivity for the developers within the US. The drug may also be eligible for fast-track approval, which means that the FDA will prioritise its application and respond to it more quickly than for other non-fast track drugs. For more information about the FDA’s Orphan Drug Designation, click here to visit their website.
