Drug intelligence / Profile preview

SP-103

Development stage
Phase 2
Lead developer
Scilex Holding
Modality
Small Molecules, Transdermal Patches → Device-based Delivery → Drug Delivery Systems, Hydrogel Systems → Drug Delivery Systems
Administration
Topical, Transdermal
01

Overview

SP-103 is a next-generation, triple-strength topical system containing 5.4% lidocaine, developed as a non-aqueous adhesive patch for the treatment of acute low back pain (LBP) and other musculoskeletal pain disorders. It is designed to deliver three times the amount of lidocaine per application area compared to ZTlido (1.8%), using the same adhesive drug delivery technology. The increased drug load aims to provide enhanced localized analgesia without increasing systemic toxicity or application site reactions, as demonstrated in Phase 2 clinical trials. SP-103 has received Fast Track designation from the FDA for low back pain and is being developed by Scilex Holding Company as a non-opioid alternative for acute and chronic pain management[2][3][6][8].

Other names
lidocaine topical system 5.4%triple-strength formulation of ZTlido
02

Targets

NaV alpha (Voltage-gated sodium channel alpha subunit family)

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