Sorrento Therapeutics, Inc., Submits NDA for ZTlido™ Next-Generation Lidocaine Patch
PRNewswire: August 29, 2017 – SAN DIEGO, CA, U.S.A. – Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), announced today that Scilex Pharmaceuticals Inc. (“Scilex”), a majority-owned subsidiary of Sorrento, resubmitted the NDA and responded to all of FDA comments related to the initial NDA submission for its lead product candidate, ZTlido™ (lidocaine patch 1.8%).
ZTlido is a next-generation non-opioid, lidocaine patch currently in development for the relief of pain associated with post-herpetic neuralgia (PHN), a severe neuropathic pain condition.
ZTlido anhydrous patch is based on a novel and proprietary technology that delivers bioequivalent levels of lidocaine to Lidoderm® (lidocaine patch 5%), which has been confirmed in two separate clinical studies. Scilex has also confirmed bioequivalence between ZTlido and Versatis® (lidocaine medicated plaster 5%), which is the European brand name for the comparator product. A clinical adhesion study demonstrated that greater than 90% of the subjects had greater than 90% adhesion over the 12 hour administration period using an FDA-recommended five-point scale. In a separate clinical study, ZTlido demonstrated strong adhesive properties even during moderate exercise with no meaningful impact on pharmacokinetics.
The novel technology allows ZTlido to achieve the ability to deliver a bioequivalent therapeutic dose of lidocaine for the treatment of PHN pain, but does so with a drug load of 36 mg/patch versus 700 mg/patch for Lidoderm and Versatis. This biopharmaceutic efficiency leads to an approximate 30-fold reduction in residual drug in ZTlido after use compared to Lidoderm and Versatis, which can significantly reduce safety risks to children and pets, and presents less drug waste entering the environment when discarded after use.
“We are excited about the opportunity to bring to the market a product that will adhere during the full prescribed treatment period as well as be able to be worn during exercise,” said Anthony Mack, president of Scilex Pharmaceuticals. “As a company, our desire is to help patients by developing better products to treat pain.”
“The state-of-the-art manufacturing technology used for ZTlido production enables high drug delivery efficiency with strong adhesive properties. The thought behind this lidocaine patch product exemplifies Sorrento’s commitment to bringing life-enhancing therapies to patients in need,” said Dr. Henry Ji, chairman and CEO of Sorrento.
If the NDA is accepted by the FDA, the review clock could be six months. If approved, ZTlido could be ready for commercial launch in the United States in 2018.
The company intends to submit a marketing authorization application for ZTlido in Europe in the fourth quarter of this year. Total 2016 sales of currently approved prescription lidocaine patches, in the United States and Europe, were approximately $750 million, and we expect ZTlido to be a significant player in the market.
