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

30/10/2024 - 18:00

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.
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-Genera...