Scilex Holding Company announced that the FDA has approved its request for Orphan Drug Designation for colchicine for the treatment of pericarditis.
Orphan drug designation is granted to drugs intended to treat rare diseases or conditions affecting fewer than 200,000 individuals in the United States. If the product receives the first FDA approval for this indication, it will be entitled to seven years of market exclusivity.
This designation highlights the potential for Gloperba®, Scilex's liquid oral colchicine formulation, to address an unmet medical need beyond its current indication for gout flares. The liquid formulation offers advantages such as adjustable dosing for specific patient populations.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.