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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. • Market research suggests SP-103 could achieve peak sales of $1.2 billion annually within six years post-launch, driven by substantial utilization intent. • Scilex is also considering strategic options to maximize company value, including a potential spin-off or public listing of Scilex Pharmaceuticals Inc.

Scilex Pharmaceuticals, a subsidiary of Scilex Holding Company, has announced a successful end-of-Phase II meeting with the FDA, securing an agreed-upon path forward for a New Drug Application (NDA) for its lead product candidate, SP-103. This next-generation formulation of ZTlido is designed to treat chronic neck pain associated with muscle spasms.

SP-103: A Potential Blockbuster for Chronic Neck Pain

SP-103 (lidocaine topical system) 5.4% represents a triple-strength formulation of ZTlido, leveraging a higher concentration of lidocaine to potentially enhance therapeutic response. The U.S. market for low back and neck pain is substantial, estimated at $134.5 billion. According to market research by Syneos Health Consulting, SP-103 has the potential to reach peak sales of $1.2 billion annually within six years of 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," said Dmitri Lissin, M.D., Chief Medical Officer of Scilex. "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."

Clinical and Commercial Strategy

Scilex plans to initiate Phase 3 trials for SP-103, building on the Phase 2 data and the FDA's guidance. The company believes its technology allows for a much higher lidocaine concentration compared to other topical lidocaine systems, which is crucial for achieving a therapeutic response. Scilex already has three FDA-approved commercial products, including ZTlido for postherpetic neuralgia, ELYXYB for acute migraine, and Gloperba for gout flare prophylaxis.

Strategic Considerations

Scilex Holding Company's Board of Directors is exploring options to maximize the value of Scilex and its subsidiaries, including a potential spin-off or public listing of Scilex Pharmaceuticals Inc. This strategic review aims to capitalize on the potential of SP-103 and Scilex's existing portfolio of pain management products.
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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'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.

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.
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Reference News

[1]
Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of - GlobeNewswire
globenewswire.com · Oct 30, 2024

Scilex Holding Company announces successful Phase II meeting with FDA, paving the way for NDA submission for SP-103, a t...

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