Scilex Receives FDA Guidance for SP-103, a Novel Topical Treatment for Chronic Neck Pain
Key Insights
Scilex Pharmaceuticals (search) secured FDA agreement on the NDA path for SP-103, a high-concentration lidocaine topical system, after a successful end-of-Phase II meeting.
SP-103, a triple-strength formulation of ZTlido, targets chronic neck pain (search) associated with muscle spasms (search), addressing a significant market estimated at $134.5 billion.
Market research projects SP-103 could achieve peak sales of $1.2 billion annually within six years post-launch, driven by substantial utilization intent.
Scilex Pharmaceuticals (search), a subsidiary of Scilex Holding Company (search), has announced a successful end-of-Phase II meeting with the FDA regarding its investigational drug, SP-103 (lidocaine topical system) 5.4%. This agreement paves the way for a New Drug Application (NDA) submission upon completion of Phase III trials. SP-103 is being developed for the treatment of chronic neck pain (search) associated with muscle spasms (search).
Addressing Chronic Neck Pain
Chronic neck pain (search) represents a substantial burden, with the U.S. low back and neck pain market estimated to reach $134.5 billion. SP-103, a next-generation, triple-strength formulation of ZTlido, aims to provide a more effective topical treatment option. According to market research by Syneos Health Consulting, SP-103 has the potential to achieve peak sales of $1.2 billion annually within six years of launch.
Clinical and Strategic Implications
Dmitri Lissin, M.D., Chief Medical Officer of Scilex, stated, "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... 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."
Scilex Holding Company (search)’s Board of Directors is also exploring strategic options to maximize the value of Scilex and its subsidiaries, including a potential spin-off or public listing of Scilex Pharmaceuticals (search) Inc.
Scilex's Existing Portfolio
Scilex currently markets three FDA-approved products:
- ZTlido® (lidocaine topical system) 1.8%: For the relief of neuropathic pain associated with postherpetic neuralgia. Gross sales have grown by an average of 50% over the past two years. Distribution outside the U.S. is expected to begin in 2025.
- ELYXYB®: An oral solution for the acute treatment of migraine, with or without aura, in adults. The U.S. oral migraine drug market was estimated at $1.8 billion in 2022. A New Drug Submission has been filed in Canada.
- Gloperba®: A liquid oral version of colchicine for the prophylaxis of painful gout flares in adults. The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028.