Innovator’s Pitch Challenge


Thursday, March 16
9:00 – 10:00am ET

Phase 2 sustained-release injectable drug for $3.6B lumbar radicular pain market utilizing patented micro-suspension platform technology. SpineThera’s lead investigational drug product, SX600, is a novel formulation of dexamethasone being developed for lumbar radicular pain to address the safety (FDA warning statement), efficacy (short-acting), and regulatory deficiencies (off-label) of existing drugs available for epidural steroid injections. This is a $3.6 billion opportunity in the U.S. sciatica market with a larger global opportunity. In our recently completed Phase 2 trial, 64% of patients reported >50% reduction in pain for 180 days from a single epidural injection. These are best-in-class results. SpineThera now seeks to move SX600 into Phase 3 development towards FDA 505b2 approval.

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Jeff Missling