SRNE - Scilex Holding gets FDA sNDA approval for Ztlido label expansion

Scilex Holding, an over 99% owned subsidiary of Sorrento Therapeutics ([[SRNE]] -2.8%), has received a supplemental new drug application ((sNDA)) approval from the U.S. FDA for ZTlido to make efficacy labeling change with clinical data.ZTlido (lidocaine patch) 1.8% is indicated for the treatment of pain associated with post herpetic neuralgia (shingles).It is the only lidocaine topical system that has been studied under the water stress conditions, and now has FDA label reflecting its use while showering, swimming and bathing, the company said.It gives polymer-based ZTlido a competitive edge as other systems, especially water-based or hydrogel-based formulations, cannot be used when wet and must be removed prior to water exposure, Sorrento said.

For further details see:

Scilex Holding gets FDA sNDA approval for Ztlido label expansion