Ztlido 5.4% (lidocaine topical patch 5.4%) / Sorrento - LARVOL DELTA

Scilex Holding Company announces successful FDA audit of enhanced ZTlido manufacturing facility in Japan (BioSpace) - "Scilex Holding Company...today announced the successful completion of a Good Manufacturing Practices (GMP) inspection by the U.S. Food and Drug Administration (FDA) of the enhanced manufacturing facility of Oishi Koseido Co., Ltd. (Oishi) for ZTlido located in Tosu, Saga, Japan. This successful audit allows Scilex to continue commercializing ZTlido product manufactured at 250kg scale at Oishi’s facility. This facility is also the manufacturing site for SP-103 (lidocaine topical system, atriple strength formulation of ZTlido) that recently completed trials in acute back pain and neck pain."

Commercial • Back Pain • CNS Disorders • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Topical Delivery Systems Effectively Transport Analgesics to Areas of Localized Pain via Direct Diffusion. (PubMed, Pharmaceutics) - "An investigational TDS containing 108 mg lidocaine (SP-103, 5.4% lidocaine), a commercially available TDS containing 36 mg lidocaine (ZTlido, 1.8% lidocaine), and a topical pain relief gel (Pennsaid, 2% diclofenac) were tested...The data showed a clear contribution of diffusive transport to lidocaine concentration, with SP-103 5.4% resulting in a significantly higher lidocaine concentration in muscle tissue than commercially available ZTlido (p = 0.008). These results indicate that SP-103 5.4% is highly effective in delivering lidocaine into muscle tissue in areas of localized pain for the treatment of musculoskeletal pain disorders (e.g., lower back pain)."

Journal • Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Scilex Holding Company Announces New Data From Deeper Skin Penetration Studies to Support SP-103 (lidocaine topical system) 5.4%, a Triple Strength Formulation of ZTlido, in Treatment of Musculoskeletal Pain Disorders (BioSpace) - "Scilex Holding Company...today announced a peer-review publication which contains results of skin penetration studies conducted at the Institute for Biomedical Research and Technologies, Graz, Austria. A set of studies assessed drug delivery from SP-103, ZTlido and control (Pennsaid®, 2% diclofenac) using open flow microperfusion. Interstitial fluid from the dermis, subcutaneous adipose tissue, and muscle was continuously sampled to assess drug penetration in all tissue layers. Ex vivo and in vivo experiments showed a higher diffusive transport of lidocaine compared to diclofenac. The data showed a clear contribution of diffusive transport to lidocaine concentration, with SP-103 resulting in a significantly higher lidocaine concentration in muscle tissue than commercially available ZTlido (p = 0.008)."

Preclinical • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Scilex Holding Company Announces the Completion of its SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido, Phase 2 trial which achieved its objectives to Evaluate the Safety and Efficacy of SP-103 in Subjects with Moderate to Severe Acute Lower Back Pain (LBP) (GlobeNewswire) - P2 | N=75 | NCT05096494 | Sponsor: Scilex Pharmaceuticals, Inc. | "Scilex Holding Company...announced the completion of its SP-103 Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy in subjects with acute LBP....Increase in lidocaine load in topical system by three times, compared with approved ZTLido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. A meaningful reduction of pain over the first week, using SPID-7 analysis, -1.5 (95% CI: -0.2 to 3.2) was observed in sub-population of patients with higher severity of muscle spasms. Overall, the trial achieved its objective..."

P2 data • Trial completion • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Scilex Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Musculoskeletal Pain • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Scilex Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Back Pain • Musculoskeletal Pain • Pain

Scilex Holding Company Announces Complete Enrollment of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido, for the Treatment of Acute Low Back Pain (GlobeNewswire) - "Scilex Holding Company...announced complete enrollment in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% triple strength formulation for ZTlido®, in subjects with acute LBP....Scilex expects to get top line data in the third quarter of 2023. The outcome of the Phase 2 study should enable planning of a subsequent Pivotal Phase 3 trial."

P2 data • Trial status • Back Pain • CNS Disorders • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Scilex Pharmaceuticals, Inc. | Trial completion date: Dec 2022 ➔ May 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Back Pain • Musculoskeletal Pain • Pain

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) (GlobeNewswire) - "Scilex Holding Company...announced that FDA has granted fast track designation for its investigational drug and device product candidate, SP-103..."

Fast track designation • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Scilex, a Sorrento Company, Announces Initiation of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 in Subjects with Acute Low Back Pain (GlobeNewswire) - "Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain....Scilex expects to complete this trial in one year. The outcome should enable planning of subsequent phase 3 trial(s)."

Trial completion date • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Scilex Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Musculoskeletal Pain • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Scilex Pharmaceuticals, Inc. | Initiation date: Dec 2021 ➔ Mar 2022

Trial initiation date • Back Pain • Musculoskeletal Pain • Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (clinicaltrials.gov) - P2; N=80; Not yet recruiting; Sponsor: Scilex Pharmaceuticals, Inc.

Clinical • New P2 trial • Back Pain • Musculoskeletal Pain • Pain

Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Scilex Pharmaceuticals, Inc.

New P1 trial

Scilex Holding Announces Strong ZTlido Sales Growth After Successful Post-Merger Integration (GlobeNewswire, Sorrento Therapeutics, Inc.) - "New focus on operational excellence in support of commercial launch of ZTlido® (lidocaine topical system) 1.8%....Gross sales [ZTlido®] in the past three months have shown strong and sustained month-over-month growth, increasing from approximately $1 million in March, to $2.4 million in April and $3.3 million in May, respectively....SP-102 phase 3 clinical trial remains on track to be completed by first half of 2020. 2) The 5.4% (3X strength) lidocaine topical system is being evaluated for a lower back pain indication in an upcoming phase 2 trial expected to start in the second half of 2019."

Clinical • Commercial • Launch • New trial