The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZTlido® (lidocaine topical system; Scilex Pharmaceuticals) to include additional administration-related data.
ZTlido is indicated for the relief of pain associated with postherpetic neuralgia in adults. The product is available as a single-layer, drug-in-adhesive topical delivery system containing 36mg of lidocaine in a polymer-based formulation. The updated labeling includes instructions for healthcare providers and patients on how to use ZTlido when exposed to water, such as showering for 10 minutes or immersion for 15 minutes.
The sNDA approval was based on a phase 1 study (ClinicalTrials.gov: NCT04784728) that evaluated the adhesion performance and pharmacokinetics of ZTlido 1.8% in 24 healthy adults while swimming, showering, and under normal conditions. Results showed that when wet, ZTlido can be successfully reapplied, if needed, and remains adhered for up to 12 hours. Findings also showed that the topical system may be used while showering and that this does not affect lidocaine plasma levels.
“We are very pleased with the trial outcome and labeling revision that attests to characteristics of ZTlido superior to other topical systems, to give patients a more reliable and uninterrupted drug delivery to alleviate pain associated with postherpetic neuralgia,” said Dmitri Lissin, MD, Chief Medical Officer of Scilex.
ZTlido 1.8% is supplied as a single-dose topical system packaged in an individual envelope. One system provides equivalent lidocaine exposure to 1 Lidoderm (lidocaine patch 5%).
1. Scilex Holding, a subsidiary of Sorrento, has received from FDA a sNDA approval for ZTlido® label expansion. [press release]. Palo Alto, CA: Sorrento Therapeutics, Inc.; April 9, 2021.
2. Roca, Rigoberto. Supplement Approval: Scilex Pharmaceuticals Inc. US Food and Drug Administration; April 8, 2021.