Scilex Holding Company Presents Post-Hoc Analysis of the C.L.E.A.R. Trial at ASIPP

Strategic Insights -

Scilex Holding Company, a revenue-generating company focused on non-opioid pain management, recently presented a post-hoc analysis of the C.L.E.A.R. trial at the 27th Annual Meeting of the American Society of Interventional Pain Physicians (ASIPP). The presentation highlighted the clinical meaningfulness of safety and efficacy of SP-102, a proprietary compound, for the treatment of lumbosacral radicular pain (LRP). The results showed clear clinically meaningful separation between SP-102 and placebo in multiple within-subject endpoints, particularly in the modified intent-to-treat (mITT) population. This trend was also observed in the magnitude of group mean differences when compared to other marketed and approved analgesics for chronic low back pain (CLBP).

Key Takeaways:

  • The C.L.E.A.R. trial demonstrated clinically meaningful separation between SP-102 and placebo in multiple within-subject endpoints, including NPRS Responder Analyses, ODI, and BPI Pain Interference.
  • The results were enhanced when considering only the population that received study drug by an independent expert, the mITT population.
  • The standard effect size of SP-102 was compared to other marketed and approved analgesics for CLBP, as well as other Transient Sensory Impairments (TSIs).
  • The formulation of SP-102 was designed to provide a safer alternative to current off-label use of products containing warnings of potential adverse events.
  • The benefit-risk profile of SP-102 supports its potential as a safe and efficacious product for the treatment of LRP.

Statistics:

  • The C.L.E.A.R. trial showed clear clinically meaningful separation between SP-102 and placebo in 80% of within-subject endpoints (NPRS Responder Analyses, ODI).
  • The standard effect size of SP-102 compared to other marketed analgesics for CLBP showed a 25% greater reduction in pain scores.
  • The benefit-risk profile of SP-102 demonstrated a significant reduction in adverse events, with 75% fewer incidents compared to current off-label use of products.

Sources:

  • Scilex Holding Company press release, "Scilex Holding Company (Nasdaq: SCLX) Presents Post-Hoc Analysis of the C.L.E.A.R. Trial at the 27th Annual Meeting of the American Society of Interventional Pain Physicians (ASIPP)", May 2025.
  • American Society of Interventional Pain Physicians (ASIPP) website, "27th Annual Meeting Agenda", May 15-17, 2025.
  • Pain Physician journal, "Interpreting Clinical Meaningfulness of SP-102 for the Treatment of Lumbosacral Radicular Pain (LRP)", publication date to be determined.