CL-108 reduces opioid-induced nausea and vomiting

  • Zuniga JR & al.
  • Pain Med
  • 17 Jan 2019

  • curated by Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • CL-108, a drug combination of a low-dose antiemetic and an analgesic for acute postoperative pain, reduced the incidence of opioid-induced nausea and vomiting (OINV) by 64% vs analgesia alone, and significantly reduced pain vs placebo.

Why this matters

  • Following opioid treatment for postoperative acute pain, 40% of patients report nausea and 20% report vomiting.
  • Patients with OINV have significantly higher hospital and medical visits and additional prescription needs than those without OINV.

Study design

  • This double-blind placebo- and active-controlled trial evaluated 466 patients who underwent surgical extraction of ≥2 impacted third molar teeth and were in moderate-to-severe pain.
  • Patients were randomly allocated to either CL-108, HC/APAP, or placebo.
  • Coprimary outcome: OINV incidence and time-weighted sum of pain intensity differences over 24 hours (SPID24).
  • Funding: Olas Pharma, Inc.

Key results

  • OINV incidence was significantly greater among HC/APAP vs CL-108 (31.7% vs 11.4%; P<.001 treated patients representing a relative reduction in risk for developing oinv with cl-108 treatment.>
  • CL-108 significantly reduced pain intensity vs placebo (SPID24, 16.2 vs 3.5; P<.001>
  • No unexpected or serious adverse events were reported.

Limitations

  • Use of enrichment procedure to enroll only patients prone to develop nausea.

Coauthored with Antara Ghosh, PhD