MALVERN, Pa., July 14, 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 commenced dermal safety studies of its Ztlido (lidocaine patch 1.8%) product candidate, a next-generation branded lidocaine patch for the treatment of postherpetic neuralgia, or PHN, also referred to as "after-shingles pain." The Company expects that the studies will be completed in the fourth quarter of 2014. The Company previously announced the commencement of the pivotal pharmacokinetic (PK) study of Ztlido. No other studies are required at this time.
SCILEX intends to seek FDA approval to market Ztlido for the treatment of PHN, a market which has been dominated by Lidoderm® (lidocaine patch 5%). The Company believes that Ztlido's differentiated attributes, which include its pliability, lack of water content and lower active pharmaceutical ingredient, will allow it to compete effectively against Lidoderm and its generic equivalents.
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 ("NDA") 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, the expected timing of clinical trials, SCILEX's intention to seek FDA approval to market Ztlido for the treatment of PHN and the ability of Ztlido, if approved, to compete with Lidoderm and its generic equivalents 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.
For more information contact:
SCILEX Pharmaceuticals, Inc.
© 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
SOURCE SCILEX Pharmaceuticals, Inc.