Drugs / SP-102
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03613662 | Jul 2018 → Mar 2019 | radiculopathy | Semnur Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07579351 | Feb 2027 → Nov 2028 expected | sciatica | Semnur Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03372161 | Dec 2017 → Aug 2021 | radiculopathy | Scilex Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-06-14 | Scilex Pharmaceuticals, Inc. | Results Scilex Holding Company Announces Publication in PAIN Journal Regarding Phase 3 Results of the Pivotal Registration Trial of SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica) gcs-web.com ↗
The Phase 3 study results are being published in PAIN® Journal, which is the leading journal devoted to pain medicine and research. |
| 2023-11-02 | Scilex Pharmaceuticals, Inc. | Regulatory Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica) gcs-web.com ↗
The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application (“NDA”). |
| 2023-03-24 | Scilex Pharmaceuticals, Inc. | Results Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary, Announces Highly Significant Positive Top-Line Results from its Phase 3 Non-Opioid Injectable SP-102 (SEMDEXA™) Pivotal Trial C.L.E.A.R. Program for Sciatica Pain Management Supporting the gcs-web.com ↗
Scilex Holding Company, a commercial-stage, non-opioid biopharmaceutical pain management company, announces highly significant positive top-line results from its Phase 3 SP-102 (SEMDEXA™) Pivotal Trial C.L.E.A.R Program for its novel, non-opioid, corticosteroid formulation, injectable dexamethasone sodium phosphate viscous gel product for the treatment of lumbosacral radicular pain (sciatica). |
| 2023-03-24 | Scilex Pharmaceuticals, Inc. | Results Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., Announces Final Results for SP-102 (SEMDEXA™) Efficacy and Safety from its Pivotal Phase 3 Clinical Trial Program for Sciatica Pain Management Supporting the Potential for First to Market Opportunity gcs-web.com ↗
SP-102 (SEMDEXA™) showed continued reduction of pain beyond one month, and the median time to open-label repeat injection was 99 days (95% CI: 78, 129 days) according to a Kaplan-Meier estimation. |
| 2023-03-23 | Scilex Pharmaceuticals, Inc. | Results Scilex, a Sorrento Company, Announces Pivotal Phase 3 SP-102 (SEMDEXA™) Data Presentation At The American Society Of Interventional Pain (ASIPP) 2022 Annual Meeting gcs-web.com ↗
The study met its primary endpoint with a highly statistically significant reduction in average daily leg pain in patients receiving SEMDEXATM compared to placebo (p<0.001). |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SP-102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03613662 ↗ |
| Route | Other | “delivered by transforaminal injection” PMID 38875121 ↗ Jun 2024 |