Ztilido is Scilex's first product in development and aims to be in a position to capitalize on the approximately $1.45 billion market created by the patent expiration of Lidoderm® (lidocaine patch 5%) as a differentiated and best in class lidocaine transdermal preparation in this segment. This study follows the filing of an investigational new drug (IND) application in March 2014. FDA notified Scilex on April 29, 2014 that the study may proceed in accordance with the protocol submitted in the IND.
"We are excited to begin the next phase towards commercialization of Ztilido for postherpetic neuralgia. This important milestone is on track with our targeted development timeline," said Anthony Mack, Co-Founder of Scilex.
The pivotal PK study is designed to recruit sixty-four healthy volunteers and to characterize the systemic exposure, pharmacokinetics, bioequivalence, and safety of the investigational lidocaine patch, and to compare the pharmacokinetics between Ztilido and Lidoderm®.
The pivotal clinical study is being conducted in accordance with advisement received from FDA's Division of Anesthesia and Analgesia Drugs (DAAP) to establish the safety and efficacy of Ztilido in support of a new drug application (NDA) submitted under 505(b)(2) regulations. Scilex is also conducting a series of clinical safety studies that will also be included in the NDA. The clinical safety studies will commence in June 2014. The Company expects to file the NDA in the fourth quarter of this year.
The Company is working with Clinipace Worldwide to oversee the development program and TKL Research as its contract research organization for the conduct of the clinical studies.