FDA Accepts SCILEX Pharmaceuticals’ NDA Filing for ZTlido™
Malvern, PA, September 16, 2015 – SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of products focused on the treatment of pain, today announced that the FDA has accepted for filing its new drug application for ZTlido™ (lidocaine patch 1.8%).
This marks a significant step on the path to commercialization for ZTlido™, following the recent filing of SCILEX’s NDA for the product as part of its 505(b)(2) regulatory pathway during the third quarter of 2015.
ZTlido™ is SCILEX’s flagship product, a branded fourth-generation patch being developed for the treatment of postherpetic neuralgia, or after-shingles pain.
In addition to the progress with ZTlido™, SCILEX is expanding its product suite for the treatment of pain with the development of several other products.
About SCILEX Pharmaceuticals
SCILEX Pharmaceuticals, Inc., located in Malvern, PA, responsibly develops and brings branded pharmaceutical products to market using groundbreaking technologies that maximize quality of life for all. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Dedicated to using our internal partnerships, we deliver the next generation of trailblazing products that are responsible by design. 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. For more information visit www.scilexpharma.com.
ZTlido™ is a trademark owned by SCILEX Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.
© 2015 SCILEX Pharmaceuticals, Inc. All Rights Reserved.
For more information contact:
SCILEX Pharmaceuticals, Inc.
MBS Value Partners, LLC