New Liquid Colchicine Dosage Form

New Liquid Colchicine Dosage Form

On January 30, 2019, the FDA has approved a new formulation of cholchicine for the prevention of gout flares in adults.  The new product, Gloperba (Romeg Therapeutics), is an oral solution to be marketed in a 0.6 mg/5 mL concentration, and is the first commercially available liquid formulation of colchicine.

The new dosage form may provide value for pediatric patients, or for adults who have difficulty swallowing solid dosage forms, and the manufacturer is also suggesting it may have value in making dosage adjustments.  It should be noted, however, that colchicine does not generally require precise dosage adjustments for the safe and effective prevention or treatment of of gout flares.  There are no specific dosage adjustment recommendations in the package label for patients with mild or moderate renal or hepatic failure, and those with severe renal or hepatic dysfunction should avoid the use of colchicine altogether.  While there is a contraindication to the use of chochicine with strong CYP3A4/5 inhibitors in patients with renal or hepatic failure, there are few other drug-drug interactions requiring colchicine dose adjustment.  There have been no studies comparing the new liquid formulation with existing oral solid dosage forms already on the market.

The new liquid formulation is expected to be available in the summer of 2019.

References Additional reporting  on this new drug approval can be found on Medscape using this link.

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