Scilex Holding /Sorrento Therapeutics has received a sNDA approval from the FDA for ZTlido to make efficacy labeling change with clinical data for post-herpetic neuralgia.

Scilex Holding an over 99% owned subsidiary of Sorrento Therapeutics has received a supplemental new drug application (sNDA) approval from the FDA for ZTlido to make efficacy labeling change with clinical data. ZTlido is the only lidocaine topical system approved fro that has been studied under the water stress conditions, and now has FDA label reflecting its use while showering, swimming and bathing. 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. In the previous clinical trial (NCT04784728), a randomized, crossover, adhesion performance and pharmacokinetic study under conditions of water exposure in healthy subjects, Scilex had demonstrated that upon immersing the lidocaine topical system 1.8% (ZTlido ) in water, wet topical systems can be successfully reapplied, if necessary, and remain adhered for up to the labeled administration period of 12 hours. The trial showed that the topical system may be used while showering and that this does not increase lidocaine plasma levels. The topical systems were well-tolerated under all conditions and the dermal irritation profile was benign.