Scilex’s Colchicine Granted FDA Orphan Drug Designation For Pericarditis Treatment

Scilex Holding Company has announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation to colchicine for treating pericarditis, a rare inflammatory heart condition. This marks a milestone in the company’s expansion beyond non-opioid pain management. It now targets diseases like pericarditis through its recent joint venture with IPMC Company, focused on neurodegenerative and cardiometabolic disorders.

The company’s product Gloperba®, a liquid oral colchicine formulation of 0.6mg concentration in 5ml that offers an alternative to traditional pill-based medications. Its oral formulation benefits patients who struggle to swallow pills and allows for more flexible dosing and titration, which is especially helpful for populations such as gout sufferers with renal or liver impairments. These features are expected to enhance both tolerability and treatment compliance.

According to the Orphan Drug Act, the designation enables medical research for diseases which affect populations of up to 200,000 people in the U.S. The orphan designation from the FDA grants a drug developer exclusive market rights for seven years and possible tax benefits and other development incentives after gaining formal FDA approval.