FDA OKs First Liquid Form of Gout Drug Colchicine (Gloperba)

The US Food and Drug Administration (FDA) has approved Gloperba (Romeg Therapeutics) oral solution 0.6 mg/5 mL, the first liquid formulation of colchicine, for prophylaxis of gout flares in adults.

Colchicine has been used for decades to treat the disease, but dose adjustments are often required for various reasons.

“Compared with currently available capsule and tablet formulations of colchicine, Gloperba oral solution allows physicians to easily make dosage adjustments for their patients,” the company said in a news release announcing approval. The liquid formulation will also be useful for patients who have difficulty swallowing pills.

The company said Gloperba will be available at chain, independent, and specialty pharmacies, as well as long-term care facilities and hospitals across the United States in the summer of 2019.

“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, Woburn, Massachusetts, said in the 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,” said Vishnupad.

Romeg Therapeutics did not conduct a side-by-side study of the Gloperba oral solution with tablet colchicine, according to an email sent to Medscape Medical News.

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