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FDA Approves Gloperba Oral Solution for Gout Flares

FirstWord Pharma news release; 2019 Feb 26

ROMEG Therapeutics has announced that the US Food and Drug Administration (FDA) approved Gloperba (colchicine) Oral Solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults. Gloperba is the first liquid formulation of colchicine approved by the FDA for the prophylaxis of gout flares. ROMEG Therapeutics is headquartered in Woburn, MA.

Physicians have used colchicine to treat gout for decades, but they are often required to adjust the dose or interrupt treatment to address drug interactions or health conditions such as when patients are undergoing kidney dialysis. Compared with currently available capsule and tablet formulations of colchicine, the Gloperba oral solution allows physicians to easily make dosage adjustments. Gloperba is also beneficial for patients who cannot swallow solid doses or pills.

Dosage/administration: The dosage for Gloperba is 0.6 mg (5 mL) once or twice daily; maximum dose 1.2 mg/day. Gloperba is administered orally, without regard to meals.

Adverse reactions: The most commonly reported adverse reactions with colchicine are

gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.


ROMEG Therapeutics receives FDA approval of Gloperba (colchicine) for prophylaxis of adult gout flares. [news release]. Woburn, MA: ROMEG Therapeutics. February 26, 2019. Accessed February 28, 2019.