Scilex Holding Company 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.

Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA??, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXA??) in Lumbosacral Radicular Pain (Sciatica) with the FDA.

Scilex launched its first commercial product ZTlido®? in October 2018, in-licensed a commercial product Gloperba®? in June 2022, and launched its third FDA-approved product Elyxyb®?

in April 2023.