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Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed Path Forward to NDA Upon Completion of Phase III Trials for Blockbuster Product Candidate, SP-1...
Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed
About this update from Scilex Holding Company
[{"type":"text","content":"Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed Path Forward to NDA Upon Completion of Phase III Trials for Blockbuster Product Candidate, SP-103 (Lidocaine Topical System) 5.4%, a Next-Generation, Triple-Strength Formulation of ZTlido, for the Treatment of Chronic Neck Pain Associated with Muscle Spasms \n Successful end of Phase II meeting with FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103, for the treatment of chronic neck pain associated with muscle spasms.SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. It is estimated that the U.S. low back and neck pain market will reach $134.5 billion.6 Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach $1.2 billion annually in the 6th year post launch.As previously announced that Scilex Holding Company’s Board of Directors has authorized management to explore ways to maximize the value of Scilex Holding Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc., including by way of conducting a spinoff or public listing of securities of Scilex Pharmaceuticals Inc. PALO ALTO, Calif., Oct. 30, 2024 (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 it had a successful end of Phase II meeting with the FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103 (lidocaine topical system) 5.4%, a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain associated with muscle spasms. Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach $1.2 billion annually in the 6th year post launch. \"We are very pleased with th...