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Sorrento’s Scilex (SRNE) Obtains FDA Fast Track Designation for SP-103


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Scilex Holding Company (“Scilex”), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, today announced that the FDA has granted Fast Track Designation to its drug investigational drug and its product candidate, SP-103. Scilex is a nearly 100% (or greater than 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE).

Scilex is developing SP-103 to be a non-opioid triple strength non-aqueous lidocaine topical system for the treatment of acute low back pain. If approved, SP-103 could become the first FDA-approved topical lidocaine product for the treatment of acute low back pain. Acute low back pain can range in intensity from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. According to the CDC in 2020, low back pain was the most common type of pain reported by patients, with 25% of US adults reporting low back pain in the previous 3 months. It is estimated that LBP will have a total potential global market opportunity of approximately $10.0 billion by 2026.2

“We are delighted that the FDA has granted Fast Track designation to SP-103,” said Dr. Dmitri Lissin, Chief Medical Officer of Scilex. “The FDA’s decision to place SP-103 in a category that may allow for accelerated development and review is an important milestone for Scilex.

There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute low back pain. The market that Scilex intends to address with SP-103, if approved, includes etiologies that are currently treated with non-procedural or non-surgical interventions, and where available treatments provide inadequate pain relief. pain or cause unacceptable side effects. These treatments can include NSAIDs, antidepressants, and opioids, as well as the off-label use of lidocaine patches.

“We are very pleased that the FDA has granted Fast Track designation to non-opioid SP-103, the next-generation triple strength formulation of ZTlido®,” said Jaisim Shah, President and CEO of Scilex. There are currently very few approved treatment options for acute low back pain, a serious condition whose prevalence continues to rise, leaving this affected group with very few safe and effective treatment options to date. Receiving this designation underscores the potential of the ZTlido® platform and the need for a new therapy like SP-103 that could improve outcomes for people with this severe debilitating disease.

The safe and effective treatment of acute low back pain represents high unmet need and creates a large market opportunity. Low back pain is one of the costliest musculoskeletal conditions in industrialized countries. Experts have estimated that about 80% of Americans will suffer from low back pain in their lifetime. The annual prevalence of low back pain is 15% to 45% with a point prevalence of approximately 30% in the United States. Sixty percent of those with acute low back pain recover within six weeks and up to 80-90% recover within 12 weeks. However, the recovery of the remaining patients with low back pain is less certain. Low back pain accounts for 19% of all workers’ compensation claims in the United States.3 Americans spent at least $135 billion in 2016 treating lower back and neck pain, representing the highest expense among 154 conditions studied by the Department of the Institute for Health. Metrics and Evaluation at the University of Washington.4

Scilex’s Triple Strength SP-103 is an investigational non-aqueous lidocaine system in clinical development for acute low back pain conditions. SP-103 builds on learnings from Scilex’s FDA-approved product, ZTlido® (Topical Lidocaine System) 1.8%, as both products share the same adhesive drug delivery formulation and the same manufacturing technology. Scilex believes that, if approved, SP-103 could become the first FDA-approved topical lidocaine product for acute low back pain indications. All current uses of topical lidocaine products for acute low back pain are off-label. SP-103 has three times the drug load of ZTlido® (108mg vs. 36mg) in the same adhesive system to potentially deliver a triple level of drug to a targeted area, but maintaining the convenience of a single topical system . Additionally, SP-103 is designed to deliver a localized dose of lidocaine three times greater than any topical lidocaine product Scilex is aware of, either on the market or in development. Scilex believes that, if approved, SP-103 may be able to address the limitations of prescription lidocaine patches in the treatment of acute low back pain by delivering a higher dose of lidocaine to the application site. As part of lifecycle management, Scilex will also target localized musculoskeletal pain, acute and chronic pain, and post-operative pain management, to focus on the development and commercialization of non-opioid therapies. for patients with acute and chronic pain. Scilex plans to complete its current Phase 2 trial of SP-103, a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy in subjects with acute low back pain (LBP) in 10 American sites, in Q1-2023. The result should allow the planning of subsequent phase 3 trials. ClinicalTrials.gov link: Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Low Back Pain – Full-Text View – ClinicalTrials.gov

Under Section 561A(f)(2) of the U.S. Federal Food, Drug, and Cosmetic Act, Scilex is required to publicly disclose its expanded access policy for SP-103 (topical lidocaine system) 5.4% by September 10, 2022 (within 15 days of the date of signing the FDA Fast Track letter).

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) (“Vickers”), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive Combination Agreement (“BCA “) on March 17, 2022. Upon closing of the transaction, the combined company (the “Combined Company”) will be renamed Scilex Holding Company, and its common stock and common stock warrants are expected to trade on Nasdaq under the symbol “SCLX” and “SCLXW”, respectively. The boards of directors of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. Closing of the transaction, which is expected to occur in the third quarter or early fourth quarter of 2022, is subject to Vickers and Scilex shareholder approvals and the satisfaction or waiver of certain other customary closing conditions.