In a press release earlier this week, SCILEX Pharmaceuticals Inc. (“SCILEX”), a subsidiary of Sorrento Therapeutics, Inc. announced the achievement of key endpoints in a bioequivalence study of its new product for the treatment of postherpetic neuralgia (PHN). ZTlido™, or lidocaine patch 1.8%, met a primary endpoint establishing comparative pharmacokinetics and a secondary endpoint for bioequivalence in comparison to the study reference product, Lidoderm® (lidocaine patch 5.0%). The company plans to resubmit the data to the US Food and Drug Administration as part of its new drug application during 2017. The ZTlido anhydrous patch uses proprietary technology that contains 36 mg lidocaine, in contrast to Lidoderm containing 700 mg lidocaine per patch.
As an element of the CDC 2016 Guideline for Prescribing Opioids in Chronic Pain, topical lidocaine is recommended for the management of neuropathic pain such as occurs in PHN. ZTlido is described by the maker as a “next generation” lidocaine patch with product attributes, including thinness and pliability that will lead to better management of pain from PHN. “Our market research shows that these attributes are key to enhancing patient compliance and potentially, enabling better treatment outcomes,” commented Anthony Mack, President of SCILEX.
Read the press release from the company here.
Posted on December 7, 2016