US-based Scilex Pharmaceuticals has started a major pharmacokinetic (PK) trial of its investigational product Ztilido (lidocaine patch 1.8%), a next-generation branded lidocaine patch, to treat postherpetic neuralgia, also called ‘after-shingles pain’.
The company is engaged in the development and commercialisation of late-stage pharmaceutical products focused on the treatment of this pain.
In March, the company submitted an investigational new drug (IND) application to US Food and drug Administration (FDA), which notified the company in April that the study may proceed in accordance with the protocol submitted in the IND.
Scilex co-founder Anthony Mack said the company is happy to initiate the next phase towards commercialisation of Ztilido for postherpetic neuralgia.
"This important milestone is on track with our targeted development timeline," Mack said.
Sixty four healthy volunteers will be enrolled in the trial, which is designed to characterise the systemic exposure, pharmacokinetics, bioequivalence, and safety of the investigational lidocaine patch, and to compare the pharmacokinetics between Ztilido and Lidoderm.
The trial is being carried out 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.
The company is also planning to carry out a series of clinical safety studies in June, included in the NDA, which is expected to be submitted in the fourth quarter of 2014.
Scilex is working with Clinipace Worldwide to manage the development programme and TKL Research as its contract research organisation (CRO) to carry out the clinical studies.
Ztilido is Scilex’s first product in development and is expected to be in a position to capitalise on the approximately $1.45bn 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 is working with Clinipace Worldwide to oversee the development programme and TKL Research as its contract research organisation for the conduct of the clinical studies.