Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for the treatment of lumbosacral radicular pain, a type of nerve-related pain in the lower back and legs. It is currently in Phase 3 clinical development and has received Fast Track designation from the FDA.
SP-102 is a small molecule corticosteroid. It is administered via epidural injection to reduce inflammation and pain associated with lumbosacral radicular pain. The drug is designed to deliver targeted relief to the affected nerve roots in the lumbar and sacral spine.
SP-102 is being developed by Scilex Holding Company, a biopharmaceutical company focused on pain management. Scilex is publicly traded under the ticker symbol SCLX.
SP-102 is currently in Phase 3 clinical development. It has completed two earlier trials, including a Phase 3 study and a Phase 2 study, and a second Phase 3 trial is planned but has not yet started recruiting participants.
SP-102 has been studied in three clinical trials. The completed Phase 3 trial (NCT03372161) enrolled 401 patients, and a Phase 2 trial (NCT03613662) enrolled 19 patients. A new Phase 3 trial (NCT07579351) is planned with an enrollment target of 755 patients.
SP-102 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The FDA has granted it Fast Track designation, which is intended to expedite the development and review of drugs that treat serious conditions and address unmet medical needs.