FDA Approves Liquid Colchicine Formulation for Gout

FEBRUARY 26, 2019
Kevin Kunzmann
FDAColchicine oral solution 0.6 mg/5 mL (GLOPERBA) has become the first liquid formulation of the therapy approved by the US Food and Drug Administration for the preventive treatment of gout flares.

The therapy, from ROMEG Therapeutics, is a liquid form of colchicine—a potent anti-inflammatory drug used for decades to treat gout, a form of arthritis which affects an estimated 8.7 million people in the US. According to ROMEG, the US market for colchicine products is currently about $800 million.

Gout is driven by elevated levels of uric acid in the bloodstream. Patients experience symptoms of sudden, severe pain in the joints, as well as swelling and redness. Symptoms most frequently appear at the base of the patient’s big toe, and can become chronic if left untreated.

Physicians using colchicine to treat gout are frequently required to adjust dosing or interrupt patient treatment to address the drug’s interaction with other treatments such as kidney dialysis. The new liquid, oral formulation allows physicians to make simpler dosage adjustments for their patients than current capsule and tablet formulations.

Additionally, the approved therapy may be particularly benefit to the estimated 15% of elderly patients who have difficult swallowing capsule or tablet drugs.

The FDA approval represents an “important advancement” for patients who experience recurring, painful symptoms associated with gout, ROMEG Chief Scientific Officer Naomi Vishnupad, PhD, said.

“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,” Vishnupad said in a statement. “The approval of GLOPERBA addresses a significant unmet and underserved medical need.”

ROMEG intends to make the oral, liquid formulation available at US chain, independent and specialty pharmacies, long-term care facilities, and hospitals this summer.

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