The FDA Division of Anesthesia and Analgesia Products agreed to a 505(b) regulatory pathway to obtain market approval for the product.
The company anticipates initiating the pivotal pharmacokinetic bridging clinical study in May and the other standard dermal clinical safety studies shortly thereafter.
Ztilido is a next-generation branded lidocaine patch formulation for the potential treatment of relieving the pain of post-herpetic neuralgia, also referred to as after-shingles pain.
Ztilido aims to be in a position to capitalize on the approximately $1.25bn market created by the patent expiration of Lidoderm (lidocaine patch 5%) as a differentiated and best in class lidocaine transdermal preparation in this segment.
The company believes that Ztilido’s attributes will also allow it to compete effectively against generics of Lidoderm.