Scilex announces successful end of Phase II meeting with FDA

Scilex (SCLX) Holding 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 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, with the substantial intent in utilization for SP-103 with peak sales potential projected to reach $1.2B annually in the 6th year post launch. “We are very pleased with the end of Phase II meeting and received a clear path forward to NDA for our blockbuster product candidate, SP-103. SP-103 has the potential to meet our core goal of developing leading pain management therapies to significantly improve the lives of patients for the treatment of chronic neck pain associated with muscle spasms who are seeking new effective treatments. We are looking forward to conducting Phase 3 trials and believe that Scilex is the only company with technology allowing much higher lidocaine concentration than any other topical lidocaine system treatments. Higher concentration of a drug per covered area of skin is important for achieving therapeutic response”, said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.