Drug Pipeline

FDA Approves Liquid Formulation of Colchicine for Gout Prophylaxis

The FDA has approved a liquid formulation of colchicine for the prophylaxis of gout flares among adult patients, according to a company press release.

Compared with capsule and tablet formulations, this liquid, oral formulation of colchicine (Gloperba, ROMEG Therapeutics) is intended to enable physicians to make prompt dosage adjustments to address potential drug interactions or health conditions in their patients.

“Gloperba represents an important advancement for patients who are experiencing the recurring, painful effects of gout,” Naomi Vishnupad, PhD, chief scientific officer of ROMEG Therapeutics, said in a press release. “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. The approval of Gloperba addresses a significant unmet and underserved medical need.”

In its labeling, the FDA noted that, for acute treatment of gout flares, the recommended dosage of colchicine is 0.6 mg (5 mL) once or twice daily, with a maximum dose of 1.2 mg per day. However, as this is not an analgesic medication, the FDA cautioned that colchicine should not be used to treat pain from other causes.

The most common adverse reactions — consistent with other formulations of colchicine — included diarrhea, nausea, vomiting and abdominal pain, as well as reports of neuromuscular toxicity, which may present as muscle pain or weakness.

“Physicians should ensure that patients are suitable candidates for treatment with Gloperba and remain alert for signs and symptoms of toxic reactions associated with increased colchicine exposure due to drug interactions,” the FDA noted in its labeling. “Signs and symptoms of colchicine toxicity should be evaluated promptly and, if toxicity is suspected, consider lowering the dose, interruption or discontinuation of Gloperba.”

The FDA has approved a liquid formulation of colchicine for the prophylaxis of gout flares among adult patients, according to a company press release.

Compared with capsule and tablet formulations, this liquid, oral formulation of colchicine (Gloperba, ROMEG Therapeutics) is intended to enable physicians to make prompt dosage adjustments to address potential drug interactions or health conditions in their patients.

“Gloperba represents an important advancement for patients who are experiencing the recurring, painful effects of gout,” Naomi Vishnupad, PhD, chief scientific officer of ROMEG Therapeutics, said in a press release. “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. The approval of Gloperba addresses a significant unmet and underserved medical need.”

In its labeling, the FDA noted that, for acute treatment of gout flares, the recommended dosage of colchicine is 0.6 mg (5 mL) once or twice daily, with a maximum dose of 1.2 mg per day. However, as this is not an analgesic medication, the FDA cautioned that colchicine should not be used to treat pain from other causes.

The most common adverse reactions — consistent with other formulations of colchicine — included diarrhea, nausea, vomiting and abdominal pain, as well as reports of neuromuscular toxicity, which may present as muscle pain or weakness.

“Physicians should ensure that patients are suitable candidates for treatment with Gloperba and remain alert for signs and symptoms of toxic reactions associated with increased colchicine exposure due to drug interactions,” the FDA noted in its labeling. “Signs and symptoms of colchicine toxicity should be evaluated promptly and, if toxicity is suspected, consider lowering the dose, interruption or discontinuation of Gloperba.”