Scilex Holding Company announces successful FDA audit of enhanced ZTlido® manufacturing facility in Japan
Enhanced 250kg manufacturing facility assures increased capacity to meet rapidly growing ZTlido® demand.
Two new patents previously announced covering ZTlido® in the U.S. ensures proprietary protection through January 2031
ALTO, Calif., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company
(Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating
company focused on acquiring, developing and commercializing non-opioid
pain management products for the treatment of acute and chronic pain,
today announced the successful completion of a Good Manufacturing
Practices (GMP) inspection by the U.S. Food and Drug Administration
(FDA) of the enhanced manufacturing facility of Oishi Koseido Co., Ltd.
(Oishi) for ZTlido® located in Tosu, Saga, Japan. This successful audit allows Scilex to continue commercializing ZTlido®
product manufactured at 250kg scale at Oishi’s facility. This facility
is also the manufacturing site for SP-103 (lidocaine topical system,
atriple strength formulation of ZTlido®) that recently completed trials in acute back pain and neck pain.
successful FDA GMP inspection highlights the GMP and quality assurance
of our partner Oishi’s manufacturing facility in Japan, which is
essential as we scale the commercial production of ZTlido®,”
said Jaisim Shah, Chief Executive Officer and President of Scilex. “The
successful FDA inspection for this enhanced manufacturing site marks an
important milestone for Scilex that will enable us to increase our
capacity to meet the growing demand for ZTlido®.”
previously announced, in November 2023, the United States Patent and
Trademark Office (USPTO) issued U.S. Patents No. 11,793,766 and No.
11,786,455 related to ZTlido®. The patent No. 11,793,766
titled “Non-aqueous Patch for the Relief of Pain,” covers a method of
relieving pain through the application of a lidocaine-containing
patch. The patent No. 11,786,455 titled “Non-aqueous Patch,” covers a
non-aqueous lidocaine patch with certain specifications, as well as a
method of relieving pain through the application of a non-aqueous
These patents further strengthen the
Company’s intellectual property portfolio and coverage for its lead
commercial product, ZTlido® (lidocaine topical system) 1.8%.
Scilex submitted this patent for listing in the FDA’s “Approved Drug
Products with Therapeutic Equivalence Evaluations” (the Orange Book) in