Tetra Bio-Pharma (TSXV:TBP; OTCQB:TBPMF) announced that the U.S. Food and Drug Administration (FDA) granted an orphan drug designation to the active ingredients of its PPP001 drug treating complex regional pain syndrome.
As quoted in the press release:
The Orphan Drug Designation was granted for the active moiety of the drug PPP001 and not the formulation.
The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect less than 200,000 people in the USA. This designation gives Tetra a seven-year marketing exclusivity, after drug approval by the FDA, and provides Tetra potential incentives such as access to federal grants and tax credits as well as a waiver of Prescription Drug User Fee Act filing fees.
Tetra successfully completed a placebo-controlled Phase 1a and 1b study of PPP001 in healthy volunteers and demonstrated that PPP001 can be safely consumed. “We are pleased to receive FDA Orphan Drug Designation for PPP001 and we look forward to discussing the clinical program with the US FDA that will be used to demonstrate the safety and efficacy in patients suffering from CRPS,” said Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer of Tetra.