The Food and Drug Administration has approved Gloperba (colchicine; ROMEG Therapeutics) Oral Solution for the prophylaxis of gout flares in adults. It is the first liquid formulation of colchicine to be approved by the FDA for this indication.
Gloperba is a ready-to-use solution for oral administration containing 0.6mg/5mL of colchicine. The approval was based on evidence from published literature supporting the efficacy of colchicine in patients with chronic gout. In 2 randomized clinical trials, treatment with colchicine 0.6mg twice daily was associated with a decrease in the frequency of gout flares in patients with gout initiating treatment with urate-lowering therapy.
The safety and efficacy of Gloperba for acute treatment of gout flares during prophylaxis has not been studied. It also should not be used to treat pain from other causes.
“Existing therapies do not adequately address the physician’s need to adjust dosages of colchicine to manage the toxicity profile for patients with renal and liver impairments, side effects, common drug-to-drug interactions, and age-related health disorders,” said Naomi Vishnupad, PhD, Chief Scientific Officer of ROMEG Therapeutics. “The approval of Gloperba addresses a significant unmet and underserved medical need.”
Gloperba is expected to be available in the US in summer 2019; it will be supplied in 150mL bottles.
For more information visit romegrx.com.