Drugs / SP-103
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04819581 | Aug 2019 | — | Scilex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05096494 | Apr 2022 → May 2023 | — | Scilex Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-11-02 | Scilex Pharmaceuticals, Inc. | Results 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 gcs-web.com ↗
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). |
| 2023-03-22 | Scilex Pharmaceuticals, Inc. | Regulatory 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) gcs-web.com ↗
SP-103 receives Fast Track Designation, which makes it eligible for some or all of the following: |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SP-103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05096494 ↗ |
| Route | Topical | “One topical system applied to the skin on the back for 12 hours.” NCT04819581 ↗ |