The San Diego, Calif.-based company is developing the drug-device product for the relief of pain associated with post-herpetic neuralgia.
“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,” Scilex president Anthony Mack said in prepared remarks. “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,” Sorrento chairman & CEO Henry Ji added.
If the product wins approval by the FDA, the company said it could be ready for its U.S. commercial launch in 2018. Sorrento also reportedly plans to submit a marketing authorization application for ZTlido in Europe in the fourth quarter of this year.
Sorrento’s anhydrous patch contains just 36 milligrams of lidocaine, compared to reference products Lidoderm and Versatis, which each have 700 milligrams of the painkiller.
In June, Scilex touted data from a head-to-head clinical adhesion study of its ZTlido lidocaine patch, comparing it to Versatis.