FDA grants Orphan Drug Status to Scilex Holding Co. for Colchicine to treat pericarditis

From Nasdaq Inc.: 2025-04-16 23:40:00

The FDA has approved Scilex Holding Co.’s request for Orphan drug designation for colchicine to treat pericarditis, an inflammation of the sac-like membrane around the heart, causing swelling and pain.

Gloperba, the first liquid oral version of colchicine, is now approved for prophylaxis of painful gout flares in adults. This oral solution provides easier administration for patients who have difficulty swallowing pills, offering adjustable dosing options and reducing side effects, especially for gout patients with renal or hepatic impairment.

The FDA grants orphan designation to drugs treating rare diseases affecting fewer than 200,000 individuals in the US, with limited cost recovery expectations from sales of the product.



Read more at Nasdaq Inc.: FDA Grants Scilex Holding Orphan Drug Status For Colchicine To Treat Pericarditis