SpineThera Announces Breakthrough Market Research Results for SX600 in the Management of Sciatica Pain

PLYMOUTH, Minn.--(BUSINESS WIRE)--SpineThera, Inc., a leading clinical-stage pharmaceutical company specializing in innovative injectable drugs, is thrilled to announce groundbreaking results from an independent market research study. The study underscores the enormous potential of SpineThera's SX600, a novel formulation of extended-release dexamethasone microspheres designed for transforaminal epidural injection in the management of sciatica pain.

• 63 doctors who perform an average of 29 lumbar transforaminal epidural steroid injections per week were surveyed by an independent consulting firm.
• Respondents indicated they would use SX600 in 70% of their patients.
• SpineThera estimates peak annual sales of 2.4 million doses of SX600 in the United States based on this research.

According to the independent market research study, which included input from 50 interventional pain management specialists and 13 physiatrists, doctors indicated their intention to utilize SX600 in 70% of their patients needing a lumbar transforaminal epidural steroid injection (TF-ESI) for the management of sciatica pain. These two specialties collectively perform over two-thirds of epidural steroid injections in the United States.

SpineThera's research reveals that approximately 3.5 million lumbar TF-ESIs are performed annually in the United States. Therefore, achieving 70% market penetration signifies an outstanding market potential for SX600.

The study's respondents, boasting an average of 16 years of clinical practice, reported that they administer an average of 29 lumbar transforaminal epidural steroid injections per week. When queried about their current treatment approaches involving the four injectable corticosteroids used for epidural steroid injections (all off-label), the respondents disclosed that 64% of their patients require at least one repeat epidural steroid injection within 90 days of the initial injection. Notably, this trend remained consistent for both solution and suspension steroids.

SpineThera CEO, Jeff Missling, commented on these remarkable findings, saying, "We previously reported results from our Phase 2 SALIENT clinical trial in which SX600 25 mg was associated with lasting, clinically relevant pain relief in a high proportion of patients, with 64% of patients who received SX600 25 mg experiencing at least 50% improvement in their worst daily leg pain from baseline from Day 30 through Day 180. Now, these quantitative market research results demonstrate incredible physician support for our investigational drug, SX600. We believe that SX600 has great potential to improve outcomes in the management of lumbar radicular pain."

About SpineThera

SpineThera is a clinical stage pharmaceutical company committed to improving the lives of patients by creating injectable drugs utilizing its patented micro-suspension platform technology. SpineThera’s micro-suspension provides months long sustained-release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs.

SpineThera's flagship investigational drug product, SX600, is a groundbreaking dexamethasone acetate micro-suspension injection which has been meticulously engineered as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk profile compared to current epidural steroid injections for radicular leg pain. SpineThera is based in Medical Alley, Minnesota, the global epicenter of health innovation and care.

Jeff Missling | jmissling@spinethera.com