Scilex announces successful FDA audit of enhanced ZTlido manufacturing facility | SRNE Message Board Posts


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Msg  1945 of 2010  at  11/30/2023 9:46:24 AM  by

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Scilex announces successful FDA audit of enhanced ZTlido manufacturing facility

 

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

PALO 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.

“This 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®.”

As 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 lidocaine-containing patch.

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 November 2023.



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