Scilex Holding, a Subsidiary of Sorrento Therapeutics, Announces Phase 2 Trial Results for its Leading SP-102 Program
- Complete Enrollment of Phase 2 Trial to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects with Lumbosacral Radiculopathy, a.k.a. sciatica
- All subjects experienced rapid reduction of leg and back pain following two SP-102 injection treatments, with group median for average pain in affected leg reduced over 50% throughout 28 days for each injection (100% response rate). There were no serious adverse events observed
- The current pivotal Phase 3 trial (fast track status) is proceeding as planned and has already reached near 50% enrollment completion
- Scilex expects SP-102 to be the first FDA approved non-opioid epidural injections for sciatica with the potential to replace the current 10 to 11 million off-label epidural steroid injections administered each year in the U.S.
MOUNTAIN VIEW, Calif., March 26, 2019(GLOBENEWSWIRE) – Scilex Holdings, Inc.(“Scilex”), a majority owned subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”), today announced results of a Phase 2 trial (SP-102-03), an open-label, single-arm, pharmacodynamic and safety study of repeat epidural injections of SP-102 in patients with lumbosacral radicular pain (sciatica). The trial was conducted, as part of FDA requirements for NDA submission, to characterize repeat dose pharmacodynamics (PD) with respect to hypothalamic- pituitary-adrenal (HPA) suppression using plasma cortisol levels, white blood cell count (WBC), and blood glucose levels. READ MORE »