ZTlido™ (lidocaine topical system) 1.8%
ZTlido is a next-generation lidocaine patch currently in development for the relief of pain associated with post-herpetic neuralgia (PHN), a severe neuropathic pain condition. The elderly population, individuals that have suffered a Shingles infection, HIV/AIDS and cancer patients are at the highest risk of contracting PHN.
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 5-point scale. In a separate clinical study, ZTlido demonstrated strong adhesive properties even during moderate exercise with no meaningful impact on pharmacokinetics.
The company plans to resubmit the NDA for ZTlido to the FDA and an MMA to selected markets in Europe (MHRA) in the second half of 2017. It is anticipated that ZTlido will become a commercially available product in 2018.