SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain, announced today that it has completed patient enrollment for the dermal safety studies and the pivotal pharmacokinetic study related to its investigational product Ztlido (lidocaine patch 1.8%), a next-generation branded lidocaine patch for the treatment of postherpetic neuralgia, also referred to as "after-shingles pain."
All studies are progressing on schedule and to date, there have been no serious adverse events reported. Scilex currently anticipates that these studies will be completed and full reports ready by November 2014. The Company anticipates filing the new drug application in the first quarter of 2015.
Ztlido is SCILEX's first product in development and aims to capitalize on the billion dollar market created by the patent expiration of Lidoderm® (lidocaine patch 5%) as a differentiated and best in class lidocaine transdermal product. The Company believes that Ztlido's attributes will also allow it to compete effectively against generics of Lidoderm.
Recombinant shingles vaccination found to lower dementia risk