Scilex Holding Company announced results from Market Research with Rheumatologists revealed a High degree of interest in Gloperba as a Liquid Colchicine Formulation Designed for Precision Dosing: Gloperba is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. These patients may benefit from flexible dosing offered by GloperbaScilex is well-positioned to market and distribute Gloperba®?: Scilex has a direct distribution network to national and regional wholesalers and pharmacies throughout the U.S. Scilex has an experienced commercial and managed care team that has successfully launched and grown market access for ZTlido (lidocaine topical system) to more than 225 million covered lives in the U.S. as well as successfully launching Elyxyb (celecoxib oral solution) in the U.S. in April 2023, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Notably, the American College of Rheumatology (ACR) guidelines also reflect this need.

Scilex is currently in discussions with the U.S. Food and Drug Administration (FDA) regarding the dosing recommendations for these patient populations. 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.