Scilex Holding To Seek Approval Fro mFDA For Modification Of Gloperba To Include
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Scilex Holding Company (NASDAQ:SCLX) announced its intention to seek FDA approval for a label modification of Gloperba to include dosing flexibility for patients with renal impairment. The proposed adjustments include dose adjustments for patients with mild or moderate renal or hepatic impairment, a starting dose of 0.3 mg/day for those with severe renal impairment, and a total recommended dose of 0.3 mg twice a week for patients undergoing dialysis.
March 20, 2024 | 3:02 pm
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Scilex Holding seeks FDA approval to modify Gloperba's label for better dosing guidance in renal impairment, potentially enhancing its marketability and patient reach.
The move to seek FDA approval for label modification of Gloperba by Scilex Holding indicates a strategic effort to enhance the drug's utility and marketability, particularly for patients with renal impairment. This could potentially lead to increased adoption and usage of Gloperba, positively impacting SCLX's market position and financial performance in the short term. The focus on non-opioid pain management also aligns with current healthcare trends, further supporting the potential positive impact.
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