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MALVERN, Pa., Aug. 11, 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 completed patient enrollment for the dermal safety studies and the pivotal pharmacokinetic study related to its investigational product Ztlido (lidocaine patch 1.8%), a next-generation branded lidocaine patch for the treatment of postherpetic neuralgia, also referred to as "after-shingles pain."
All studies are progressing on schedule and to date, there have been no serious adverse events reported. Scilex currently anticipates that these studies will be completed and full reports ready by November 2014. The Company anticipates filing the new drug application in the first quarter of 2015.
Ztlido is SCILEX's first product in development and aims to capitalize on the billion dollar market created by the patent expiration of Lidoderm® (lidocaine patch 5%) as a differentiated and best in class lidocaine transdermal product. The Company believes that Ztlido's attributes will also allow it to compete effectively against generics of Lidoderm.
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, Ztlido (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 Ztlido versus Lidoderm® to support approval of Ztlido pursuant to a 505(b)(2) new drug application regulatory pathway. 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 Ztlido will be in a position to capitalize on the billion dollar market created by the patent expiration of Lidoderm® as a differentiated and best in class lidocaine transdermal product, the timing of the completion and final reports for clinical studies, the filing of a new drug application 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 Ztlido 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.
Ztlido 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.
© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
For more information contact Will Pedranti:
SCILEX Pharmaceuticals, Inc.
SOURCE SCILEX Pharmaceuticals, Inc.