Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido? - Applied Clinical Trials

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Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido? Scilex has commenced with its pivotal bioequivalence study of Ztilido versus LidodermŽ in accordance with FDA recommendations to support approval of Ztilido submitted as a 505(b)(2) NDA


Scilex Pharmaceuticals Initiates Pivotal Pharmacokinetic Study for Ztilido™

Scilex has commenced with its pivotal bioequivalence study of Ztilido versus Lidoderm® in accordance with FDA recommendations to support approval of Ztilido submitted as a 505(b)(2) NDA

PR Newswire

MALVERN, Pa., May 19, 2014 /PRNewswire/ -- 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 initiated a pivotal pharmacokinetic (PK) study of its investigational product Ztilido (lidocaine patch 1.8%), a next-generation branded lidocaine patch for the treatment of postherpetic neuralgia, also referred to as "after-shingles pain."

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.

About SCILEX Pharmaceuticals

SCILEX Pharmaceuticals, Inc., located in Malvern, PA, is an emerging specialty pharmaceutical company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain. The Company's vision is to become a world-class, global pharmaceutical company that delivers the next generation of innovative products. Leveraging its network of global relationships, the Company seeks to acquire high barrier-to-entry, late-stage products for development and commercialization. The Company's first product under development, Ztilido™ (lidocaine patch 1.8%), is a next-generation branded lidocaine patch formulation for the potential treatment of relieving the pain of postherpetic neuralgia, also referred to as "after-shingles pain." The FDA Division of Anesthesia and Analgesia Products recommended that the Company conduct a pivotal bioequivalence study of Ztilido versus Lidoderm® to support approval of Ztilido pursuant to a 505(b)(2) new drug application ("NDA") regulatory pathway. The Company is currently conducting the pivotal bridging clinical study and anticipates initiating standard dermal clinical safety studies in June 2014. The Company expects to file an NDA in the fourth quarter of 2014.

For more information visit www.scilexpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking statements regarding future events and the future performance of SCILEX Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to SCILEX's  business and its future, including SCILEX's ability to develop and commercialize products for the treatment of pain, that SCILEX is moving toward the commercialization of Ztilido, that Ztilido will be in a position to capitalize on the approximately $1.45 billion market created by the patent expiration of Lidoderm® as a differentiated and best in class lidocaine transdermal preparation in this segment, the timing of the initiation of clinical studies, the filing of a New Drug Application, the Ztilido development timeline and any statements that relate to the intent, belief, plans or expectations of SCILEX or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Ztilido may not successfully bridge safety and efficacy to Lidoderm® through the planned bridging clinical study; successfully demonstrate suitable safety in the additional clinical studies; the possibility that SCILEX's future application to the FDA may not receive approval in a timely manner or at all; and SCILEX's dependence on third parties for clinical trials and manufacturing. SCILEX does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Ztilido™ is a trademark owned by SCILEX Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners. A proprietary name review by the FDA is planned.

For more information contact Will Pedranti:

SCILEX Pharmaceuticals, Inc.
William Pedranti
484.875.3032 
wpedranti@scilexpharma.com

© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.

SOURCE SCILEX Pharmaceuticals, Inc.

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