Scilex Holding Says FDA Approved Request For Orphan Drug Designation For Colchicine For Treatment Of Pericarditis

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

PALO ALTO, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (NASDAQ:SCLX, "Scilex" or "Company"))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that FDA has approved our request for the Orphan drug designation for colchicine for the treatment of pericarditis.

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. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues.