- Sorrento Therapeutics Inc's (NASDAQ:SRNE) subsidiary Scilex Holding Company has announced final results from its SP-102 Phase 3 Pivotal Trial C.L.E.A.R. Program.
- SP-102 (Semdexa) has received Fast Track status from the FDA.
- The C.L.E.A.R. Trial investigated the safety and analgesic effects of single and repeat transforaminal injections of SP-102 compared to placebo (saline injection).
- The trial enrolled 401 low back pain subjects with unilateral intervertebral disc herniation in the lumbar spine, resulting in moderate to severe leg pain radicular pain symptoms.
- SP-102 demonstrated pain relief that continued through 12 weeks.
- Related: Vickers Venture SPAC To Merge With Sorrento Therapeutics' Pain-Focused Subsidiary.
- Other pain measurements, such as worst daily and current pain in the affected leg and average daily pain in the lower back, demonstrated statistically significant results compared to placebo.
- Safety analysis demonstrated a favorable safety profile with no identified safety risks.
- SP-102 is a non-opioid novel injectable corticosteroid gel formulation product in development to treat lumbar radicular pain, and it contains no preservatives, surfactants, solvents, or particulates.
- Price Action: SRNE shares are up 1.74% at $2.64 during the market session on the last check Friday.
