The Food and Drug Administration (FDA) has granted Fast Track designation to SP-103 (lidocaine topical system) 5.4% for the treatment of acute low back pain.
SP-103 is a next generation triple strength formulation of ZTlido® (lidocaine topical system). The investigational product is designed with the same nonaqueous, adhesive drug delivery system but with 3 times the drug load of ZTildo (108mg vs 36mg).
The Company is currently evaluating the efficacy and safety of SP-103 in patients with moderate to severe acute low back pain in a randomized, double-blind, placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT05096494). The trial is expected to be completed in the first quarter of 2023.
“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 CEO of Scilex. “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.”
ZTildo 1.8% is currently approved for the relief of pain associated with postherpetic neuralgia.
Scilex Holding Company, a Sorrento Company, announces that the FDA has granted Fast Track designation for SP-103 (lidocaine topical system) 5.4%, next generation triple strength formulation of ZTlido®, for the treatment of acute low back pain (LBP). News release. Scilex Holding Company. Accessed August 31, 2022. https://www.globenewswire.com/news-release/2022/08/31/2507243/0/en/Scilex-Holding-Company-a-Sorrento-Company-Announces-That-the-FDA-Has-Granted-Fast-Track-Designation-for-SP-103-Lidocaine-Topical-System-5-4-Next-Generation-Triple-Strength-Formulat.html