12:07 PM EDT, 03/20/2024 (MT Newswires) -- Scilex Holding ( SCLX ) said Wednesday it plans to seek approval from the US Food and Drug Administration to change the label of gout drug Gloperba to add dosing guidance for people with renal impairment and other circumstances.

Gloperba -- a liquid and oral formulation of gout drug colchicine -- is used to treat gout attacks in adults, the company said.

People with "mild or moderate renal or hepatic impairment should be considered for dose adjustment," Scilex ( SCLX ) said.

The starting dose for people with severe renal impairment should be 0.3 milligrams a day, the company said, adding that people undergoing dialysis should be given 0.3 milligrams twice a week.

A market research study with rheumatologists showed a "high degree of interest in Gloperba as a liquid colchicine formulation designed for precision dosing," Scilex ( SCLX ) said.

The company said it expects to launch Gloperba in H1 2024.

Price: 1.37, Change: +0.02, Percent Change: +1.48