Phase 2 Repeat Dose Study
We conducted an open-label, single-arm, pharmacodynamics (“PD”) and safety study of repeat epidural injections of SP-102 (SEMDEXA™) in patients with sciatica. We conducted this study to characterize repeat dose PD with respect to hypothalamic-pituitary-adrenal suppression using plasma cortisol levels, white blood cell count and blood glucose levels.
The study enrolled 19 subjects, of which 15 received repeat SP-102 (SEMDEXA™) epidural injections 4 to 8 weeks after the initial injection. Four of the subjects did not experience recurrent pain and thus did not require a repeat injection. The daily average, current and worst pain in the affected leg and back showed continuous reduction throughout the 28-day observation period for both treatments. Based on a preliminary review of the results, SP-102 (SEMDEXA™) injections were generally well tolerated and there were no new unexpected adverse events observed.
