Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SP-103 · 2 trials · 2 indications
Average Lower Back Pain Numerical Pain Rating Scale Summed Pain Intensity Difference (SPID) D1 to D7 (0-10, 0 is no pain, 10 is worst pain imaginable). Daily average LBP NPRS scores, where subjects rated the intensity of their average LBP over the past 24 hours (higher scores are indicative of worse pain), were used to calculate time weighted SPID scores from D1 to D7. A higher SPID change score indicates less pain. The PID was calculated as the NPRS score at the Baseline minus the current day NPRS score. The SPID is the summed pain intensity difference for each Day (1-7).
Peak plasma concentration of lidocaine after 12 hour topical system application
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
| Arm | Type | Description |
|---|---|---|
| SP-103 | EXPERIMENTAL | One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back. |
| Placebo | PLACEBO_COMPARATOR | One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back |
| SP-103 (1 topical system) | EXPERIMENTAL | One topical system applied to the skin on the back for 12 hours. |
| SP-103 (2 topical systems) | EXPERIMENTAL | Two topical systems applied to the skin on the back for 12 hours. |
| SP-103 (3 topical systems) | EXPERIMENTAL | Three topical systems applied to the skin on the back for 12 hours. |
| ZTlido | ACTIVE_COMPARATOR | Three topical systems applied to the skin on the back for 12 hours. |
| Name | Type | Description |
|---|---|---|
| SP-103 | DRUG | SP-103 topical system is worn daily for 12 hours per day for 28 days |
| Placebo | DRUG | Placebo topical system is worn daily for 12 hours per day, for 28 days |
| ZTlido | DRUG | lidocaine topical system 1.8% |
Inclusion Criteria: * Able and willing to read, write, and understand the informed consent prior to beginning any study procedures. * Male or female, age 18 to 75 years (inclusive). * Based on medical history, current episode of lower back pain (LBP) must have been present for not more than 3 month...
SP-103 is an investigational small molecule being studied for the treatment of moderate to severe acute lower back pain. It has also been evaluated in healthy adult subjects for pharmacokinetic purposes. The drug is currently in clinical development and has not been approved by the FDA.
SP-103 is being developed by Scilex Holding Company, which trades under the ticker SCLX. The company is conducting clinical trials to evaluate the safety, efficacy, and pharmacokinetics of this investigational drug for acute lower back pain.
SP-103 is in Phase 1 clinical development, based on the most advanced completed trial. However, a Phase 2 trial has also been completed. The drug has received Fast Track designation from the FDA, but it remains investigational and is not yet approved.
SP-103 has been studied in two completed clinical trials. NCT04819581 was a Phase 1 pharmacokinetic study in healthy adults with 15 participants. NCT05096494 was a Phase 2 safety and efficacy study in 76 subjects with moderate to severe acute lower back pain. Both trials were conducted in the United States.
No, SP-103 is not FDA approved. It is an investigational drug currently in clinical development. The FDA has granted it Fast Track designation, which is intended to expedite development and review, but approval has not been granted.