Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company, announced a successful end of Phase II meeting with the FDA for its product candidate, SP-103 (lidocaine topical system) 5.4%.
The meeting resulted in an agreed path forward to a New Drug Application (NDA) upon completion of Phase III trials for SP-103, which is being developed for the treatment of chronic neck pain associated with muscle spasms.
Independent market research by Syneos Health Consulting projects that SP-103 has a peak sales potential of $1.2 billion annually in its sixth year post-launch, positioning it as a significant future revenue driver for Scilex.
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