Gloperba Approved to Treat Gout
February 26, 2019 – ROMEG Therapeutics has announced the U.S. FDA approval of Gloperba® (colchicine) Oral Solution 0.6mg/5mL to provide prophylaxis of gout flares in adults. The product is the first liquid formulation of colchicine approved for this indication.
An estimated 8.7 million individuals in the United States have gout, a form of arthritis caused by elevated levels of uric acid in the bloodstream. This causes uric acid crystals to build up in joints, causing pain, swelling, and redness.
The active ingredient in Gloperba, colchicine, has been approved to treat gout since 1961. However, dosage adjustments may often be required to meet patients’ needs, and ROMEG anticipates that Gloperba’s liquid formulation will allow for easier adjustments than can be achieved with tablet and capsule dosage forms of colchicine. It may also allow for easier treatment of patients who have difficulty swallowing tablets or capsules. Recommended dosing ranges from 0.6mg once daily to a maximum dose of 1.2mg/day. Gloperba will be available in a 0.6mg/5mL oral solution dosage strength.
Launch is expected in summer of 2019. Pricing plans have not yet been announced.