Lumbosacral Radicular Pain
SP-102 is a non-opioid epidural steroid injectable potentially for the treatment of Lumbosacral radicular pain, a common type of chronic low back pain.
Lumbosacral radicular pain is characterized by debilitating pain usually requiring medical intervention.
Currently, there are a large number of interventional back pain treatment procedures in the US (~10M) for lumbosacral radicular pain, but there are no interventional prescription pain products approved or in late-stage development for epidural use.
Currently used injectable medications are not approved for the treatment of lumbosacral radicular pain. These steroid products all have preservatives, surfactants which have been associated with serious neurologic events when administered by the epidural route. This has led the FDA to issue bold warnings due to lack of demonstrated safety and effectiveness for epidural administration and reported neurotoxicity of preservative components. In addition, all of the existing steroid products lack viscosity enhancing agents, and as a result the solution spreads away quickly from the injection site.
SP-102 Key Characteristics:
- Novel formulation with prolonged residency time at injection site
- No surfactants
- No preservatives
- No particulates
SP-102 is potentially the first non-opioid, epidural steroid injectable for the treatment of Lumbosacral radicular pain without surfactants, preservatives, or particulates. Physicians see an FDA-approved particulate and preservative-free product as novel, which could potentially avoid growing liability risk.
Currently, SP-102 is completing a Phase 1/2 clinical trial in lumbar radiculopathy, with results expected in Q4 2016. Scintilla plans to file an IND with the FDA in Q1 2017 and begin pivotal Phase 3 clinical trials in 2017.