The San Diego, Calif.-based company said it is pursuing a hybrid regulatory pathway with the Medicines and Healthcare Products Regulatory Agency in the U.K., which will serve as the lead review agency. The company also plans to file for review in other countries, including Germany, France, Spain, Italy and Ireland.
Scilex said it expects to hear back about its marketing authorization application in the fourth quarter of 2018, since the review time is 210 days. The company is also reviewing commercial options and potential partnerships for its launch in the E.U., according to Scilex.
In September, Scilex said that the FDA received the resubmitted version of a new drug application for ZTlido. The FDA is slated to finish reviewing the company’s NDA by February 28th next year.
If the product wins approval by the FDA, the company has 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, designed for the relief of pain associated with post-herpetic neuralgia, contains just 36 milligrams of lidocaine, compared to reference products Lidoderm and Versatis, which each have 700 milligrams of the painkiller.
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