Pivotal pharmacokinetic bridging clinical study anticipated to begin in May.
Malvern, PA – SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of products for the treatment of pain, today announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration for its first product Ztlido™ (lidocaine patch 1.8%). The FDA Division of Anesthesia and Analgesia Products agreed to a 505(b)(2) 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.
Ztlido™ 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. Ztlido aims to be in a position to capitalize on the approximately $1.25 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. The Company believes that Ztlido’s attributes will also allow it to compete effectively against generics of Lidoderm.
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About SCILEX Pharmaceuticals
SCILEX Pharmaceuticals, Inc., located in Malvern, PA, is an emerging specialty pharmaceutical company engaged in the development and commercialization of products for 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, Ztlido™ (lidocaine patch 1.8%), 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. The FDA Division of Anesthesia and Analgesia Products agreed to a 505(b)(2) regulatory pathway to obtain market approval.
For more information visit www.scilexpharma.com.
Forward Looking Statements
Forward-looking statement — This press release may contain 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 our business and its future, including SCILEX’ ability to develop and commercialize products for the treatment of pain, that Ztlido will be in a position to capitalize on the approximately $1.25 billion market created by the patent expiration of Lidoderm as a differentiated and best in class lidocaine transdermal preparation in this segment, that Ztlido’s attributes will allow it to compete effectively even against potential generic Lidoderm, the timing of the initiation of clinical studies, 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 our future application to the FDA may not receive approval in a timely manner or at all; and our dependence on third parties for clinical trials and manufacturing. We do not plan to update any such forward-looking statements and expressly disclaim 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 FDA is planned.
© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
For more information contact Will Pedranti:
SCILEX Pharmaceuticals
William Pedranti
949-413-2672