Approval Probability
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Adjusted LOA
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SP-102 · 3 trials · 1 indication
The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days \[D-7 to D-1\] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo.
The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
| Arm | Type | Description |
|---|---|---|
| SP-102 | EXPERIMENTAL | - |
| Placebo Comparator | PLACEBO_COMPARATOR | - |
| dexamethasone sodium phosphate | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SP-102 | DRUG | One Injection |
| Placebo | DRUG | One injection |
| Dexamethasone Sodium Phosphate 10 MG/ML | DRUG | One injection |
Inclusion Criteria: Main Inclusion Criteria: * Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures. * Age 18 to 75 years (inclusive) at the Screening Visit. * A diagnosis of lumbosacral r...
SP-102 is being developed for lumbosacral radicular pain, a condition involving pain that radiates along the lower back and legs. It is an investigational small molecule therapy studied in adults 18 years and older. Scilex Holding Company is developing it as a non-opioid treatment option for this pain condition.
SP-102 is developed by Scilex Holding Company, which trades under the ticker SCLX. The company is advancing the asset through late-stage clinical development for lumbosacral radicular pain. Scilex holds the program and its associated regulatory designations.
SP-102 is in Phase 3 clinical development for lumbosacral radicular pain. It has completed two trials and has one active Phase 3 study that is not yet recruiting. The program has received Fast Track designation from the FDA but is not approved, and it remains investigational.
SP-102 has been studied in three clinical trials. The completed studies are NCT03372161, a Phase 3 trial with 401 participants, and NCT03613662, a Phase 2 pharmacodynamics and safety study with 19 participants. The ongoing Phase 3 study is NCT07579351, which plans to enroll 755 participants and is not yet recruiting.
SP-102 trials in lumbosacral radicular pain are randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older of all sexes. Total enrollment across the three studies is 1,175 participants. The completed Phase 3 study NCT03372161 and the Phase 2 study NCT03613662 were conducted in the United States.
SP-102 has received Fast Track designation from the FDA for its development in lumbosacral radicular pain. Fast Track is intended to facilitate development and expedite review of therapies addressing serious conditions. Despite this designation, SP-102 remains investigational and is still in Phase 3 clinical development.