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Sorrento, SCILEX post-shingles pain treatment wins FDA approval

The U.S. Food and Drug Administration granted approval to Sorrento Therapeutics Inc. and its majority-owned unit SCILEX Pharmaceuticals Inc. for nonopioid painkiller ZTlido 1.8%.

ZTlido, a lidocaine topical patch, is used to treat post-herpetic neuralgia or post-shingles pain. Shingles is a viral infection that causes a painful rash.

An FDA report found that the inability of patches to remain attached to the skin was the most widely reported quality defect among systems that deliver drugs through the skin, according to Sorrento.

In a phase 1 study, ZTlido stayed on the skin for a longer period than another lidocaine patch, Endo International plc's Lidoderm.

More than 100 million prescription lidocaine patches were sold in the U.S. in 2017, Sorrento stated, citing IMS Health data.

San Diego-based biopharmaceutical company Sorrento plans to have SCILEX launch ZTlido commercially sometime in 2018. SCILEX filed an application in November 2017 to authorize marketing ZTlido in Europe.

Sorrento acquired a stake of about 72% in the Malvern, Pa.-based SCILEX Pharmaceuticals in a $47.6 million deal in November 2016.