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Scilex plans to file for FDA approval to expand use of its non-opioid pain reliever, ELYXYB, for acute pain.
Scilex Holding Company plans to file a Supplemental New Drug Application (sNDA) with the FDA for ELYXYB, a Celecoxib formulation, aiming to expand its use to acute pain.
ELYXYB is a non-opioid alternative designed for rapid and lasting pain relief, potentially reducing reliance on opioids.
The move targets a $3 billion market and follows positive clinical trial results showing significant pain reduction and patient satisfaction.
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Scilex planea solicitar la aprobación de la FDA para ampliar el uso de su analgésico no opioide, ELYXYB, para el dolor agudo.