SP-103 builds on the learnings from Scilex’s FDA-approved product, ZTlido ® (topical lidocaine system) 1.8%, because both products share the same adhesive drug delivery formulation and manufacturing technology. Scilex’s triple-strength SP-103 is an investigational, non-aqueous lidocaine topical system undergoing clinical development in acute LBP conditions. 3 Americans spent at least $135 billion in 2016 on treating low back and neck pain, which was the highest expenditure among 154 conditions studied by the Department of the Institute for Health Metrics and Evaluation at the University of Washington. LBP accounts for 19% of all workers’ compensation claims in the United States. However, the recovery of the remaining patients with LBP is less certain. Sixty percent of those who suffer from acute LBP recover in six weeks and up to 80-90% recover within 12 weeks. The annual prevalence of LBP is 15% to 45% with a point prevalence of approximately 30% in the United States. Experts have estimated that approximately 80% of Americans will experience LBP during their lifetime. LBP is one of the costliest musculoskeletal conditions in industrialized countries. The safe and effective treatment of acute LBP represents high unmet needs and creates a large market opportunity. Receiving this designation underscores the potential of the ZTlido ® platform and the need for a new therapy like SP-103 that may improve outcomes for those with this serious debilitating condition.” There are currently very limited approved treatment options for acute low back pain, a serious condition the prevalence of which continues to rise, leaving this affected group with very limited safe and effective treatment options to date. “We are very pleased that the FDA has granted Fast Track designation for the non-opioid SP-103 program, the next generation triple strength formulation of ZTlido ®,” said Jaisim Shah, President and Chief Executive Officer of Scilex. These treatments may include NSAIDs, antidepressants and opioids, as well as off-label use of lidocaine patches. The market 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 or result in unacceptable adverse effects. There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute LBP. “The FDA's decision to place SP-103 in a category that may enable expedited development and review is an important milestone for Scilex.” Dmitri Lissin, Chief Medical Officer of Scilex. “We are pleased that the FDA has granted Fast Track Designation for SP-103,” said Dr. LBP is estimated to have a total potential global market opportunity of approximately $10.0 billion by 2026. adults reporting LBP in the prior 3 months 1. According to the CDC in 2020, LBP was the most common type of pain reported by patients, with 25% of U.S. Acute LBP can range in intensity from a dull, constant ache to a sudden, sharp sensation that leaves the person incapacitated. If approved, SP-103 could become the first FDA-approved lidocaine topical product for the treatment of acute LBP. Scilex is developing SP-103 to be a non-opioid triple-strength, non-aqueous lidocaine topical system for the treatment of acute LBP. Scilex is a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. 30, 2022 (GLOBE NEWSWIRE) - 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 FDA has granted fast track designation for its investigational drug and device product candidate, SP-103. LBP is estimated to have a total potential global market opportunity of approximately $10.0 billion by 2026.adults reporting LBP in the prior 3 months. According to the CDC in 2020, LBP was the most common type of pain reported by patients, with 25% of U.S. ![]() Despite an overall lack of evidence to support their efficacy, opioids continue to be prescribed to treat acute LBP when patients seek medical evaluation.Rolling Review, which means that Scilex can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. ![]()
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