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Scilex's SP-103 Lidocaine Topical System Receives Positive FDA Feedback for Chronic Neck Pain

• Scilex Pharmaceuticals gains FDA agreement on NDA path for SP-103, a triple-strength lidocaine topical system, after a successful Phase II meeting. • SP-103 targets chronic neck pain associated with muscle spasms, with potential peak sales projected at $1.2 billion annually. • The next-generation formulation of ZTlido aims to provide more effective pain relief through a higher concentration of lidocaine. • Phase III trials are planned to further evaluate SP-103, with Scilex emphasizing its technology's advantage in delivering higher lidocaine concentrations.

Scilex Pharmaceuticals, a subsidiary of Scilex Holding Company, 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 a next-generation, triple-strength formulation of ZTlido, designed for the treatment of chronic neck pain associated with muscle spasms.
The U.S. market for low back and neck pain treatments is substantial, estimated to reach $134.5 billion. Independent market research by Syneos Health Consulting projects peak sales potential for SP-103 at $1.2 billion annually within six years of launch.

Clinical and Commercial Strategy

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”.

SP-103: A Next-Generation Topical Analgesic

SP-103 represents an advancement in topical pain relief, leveraging a higher concentration of lidocaine compared to existing formulations. This increased strength aims to enhance therapeutic efficacy in patients with chronic neck pain and muscle spasms. Scilex believes its technology uniquely enables this higher concentration, potentially offering a significant advantage over other topical lidocaine treatments.

Scilex's Existing Portfolio

Scilex currently markets three FDA-approved products:
  • ZTlido® (lidocaine topical system) 1.8%: Indicated for the relief of neuropathic pain associated with postherpetic neuralgia.
  • ELYXYB®: An oral solution for the acute treatment of migraine, with or without aura, in adults.
  • Gloperba®: A liquid oral version of colchicine for the prophylaxis of painful gout flares in adults.

Market Opportunity

Scilex is strategically targeting large markets with unmet needs. The company estimates the U.S. oral migraine drug market size at $1.8 billion in 2022 and the gout treatment market is projected to reach $2.0 billion in the U.S. by 2028. The Canadian migraine therapeutics market is estimated to reach approximately $400 million by 2025.
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Scilex Gains FDA Clarity on SP-103 Path to NDA for Chronic Neck Pain

Scilex Holding announced a successful end-of-Phase II meeting with the FDA for SP-103, a high-concentration lidocaine formulation targeting chronic neck pain.
The FDA has provided a clear pathway forward to a New Drug Application (NDA) for SP-103 upon successful completion of Phase III trials.

Scilex Receives FDA Guidance for SP-103, a Novel Topical Treatment for Chronic Neck Pain

Scilex Pharmaceuticals 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 associated with muscle spasms, addressing a significant market estimated at $134.5 billion.

Scilex's SP-103 Receives Positive FDA Feedback, Paving Way for Phase III Trials in Chronic Neck Pain

Scilex Pharmaceuticals' SP-103, a triple-strength lidocaine topical system, has received positive feedback from the FDA, clearing the path for Phase III trials.
SP-103 targets the chronic neck pain market, with potential peak sales projected to reach $1.2 billion annually within six years post-launch.

Scilex Pharmaceuticals Achieves FDA Agreement on NDA Path for SP-103 in Chronic Neck Pain

Scilex Pharmaceuticals secured FDA agreement on the NDA path for SP-103, a lidocaine topical system 5.4%, following a successful end-of-Phase II meeting.
SP-103, a next-generation, triple-strength formulation of ZTlido, targets chronic neck pain associated with muscle spasms, a market projected to reach $134.5 billion.

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Reference News

[1]
Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company ... - BioSpace
biospace.com · Oct 30, 2024

Scilex Holding Company announces successful Phase II meeting with FDA, paving the way for NDA submission upon Phase III ...

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