Scilex Reports Completion of Patient Enrollment in P-III C.L.E.A.R. Program for Semdexa (SP-102) to Treat Sciatica Pain Management

Shots:

  • The company has completed the enrollment in the P-III C.L.E.A.R. program evaluating SP-102 vs PBO in 400 patients with lumbosacral radicular pain or sciatica at 40 sites across 25 states in the US. The results are expected in Q4’21
  • The 1EPs of the study is mean change in the numeric pain rating scale for leg pain @ 4 wks. Additionally, a trial is designed to assess 2EPs including other measures of pain i.e., back pain, time to repeat injection of SP-102, safety & function @ 4 & 12 wks.
  • If approved by the FDA, SP-102 would be the 1st non-opioid epidural injection for sciatica & will be available in a pre-filled syringe. The therapy also received FT designation from the FDA

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Scilex Holding

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