FDA Grants Scilex Holding Orphan Drug Status For Colchicine To Treat Pericarditis

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(RTTNews) - Scilex Holding Co. (SCLX) announced that FDA has approved it request for the Orphan drug designation for colchicine for the treatment of pericarditis.

Pericarditis is an inflammation of the pericardium, the sac-like membrane that surrounds and protects the heart. It occurs when the pericardium becomes irritated or infected, leading to swelling and pain.

Gloperba is the first and only liquid oral version of the anti out medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

Gloperba is taken orally like cough syrup. The dosage of 0.6mg per 5ml (teaspoon) can fill that important void in treatment where patients may have difficulty swallowing pills. It can also provide more adjustable dosing, titration and dose-reduction options in specific populations, especially for gout patients with renal or hepatic impairment and reduce side effects with the goal to improve patient convenience and disease management.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in the United States for this type of disease or condition will be recovered from sales of the product.

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