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An open-label multi-center safety and efficacy trial of SP-102 (SEMDEXATM) in patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection

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Trial Profile

An open-label multi-center safety and efficacy trial of SP-102 (SEMDEXATM) in patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2023

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Sciatica
  • Focus Therapeutic Use
  • Sponsors Scilex Holding

Most Recent Events

  • 09 Nov 2023 New trial record
  • 02 Nov 2023 According to a Scilex Holding media release, SP-102 (SEMDEXATM) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment in the trial is projected to occur in 2025.
  • 02 Nov 2023 According to a Scilex Holding media release, based on the advisement received from FDA on CLEAR trial, company is planning to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it will seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection.

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