The SPA is an agreement between Spinal Restoration and the FDA that the Phase 3 study design, endpoints and planned statistical analysis are adequate to provide necessary data that, depending on outcome, could support a Biologic License Application, according to the release. Patient enrollment in the study is expected to begin in early 2010.
The Phase 3 trial is a multicenter, randomized, blinded, placebo-controlled study designed to assess the ability of the Biostat System to reduce pain and improve function in patients with chronic discogenic low back pain, according to the release. Study success will be determined by comparing the success rates between the investigational and control populations at the 6-month primary endpoint.
The Biostat System consists of BIOSTAT BIOLOGX Fibrin Sealant, a human-derived, resorbable biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation and enhancing tissue repair, according to the release.
Read the release about the Special Protocol Assessment for Biostat.
