- 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.
- 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.
- 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.
- Use of enrichment procedure to enroll only patients prone to develop nausea.
Coauthored with Antara Ghosh, PhD