Phase 4 JOURNAVX Data: Opioid-Free Recovery After Plastic Surgery

New Phase 4 data highlighted in a Vertex press release describe outcomes from a multicenter, open-label, single-arm study of JOURNAVX (suzetrigine) in adults undergoing aesthetic and reconstructive plastic surgery; the company reported that 90.9% of patients did not require rescue opioids after surgery through the end of treatment (up to 14 days) as part of multimodal therapy.

According to the release, the Phase 4 study was open-label, multicenter, and single-arm, and it enrolled 99 adults undergoing a range of reconstructive and aesthetic procedures (including breast surgeries, liposuction or abdominoplasty with liposuction, and turbinoplasties). JOURNAVX was administered preoperatively and postoperatively as part of multimodal therapy, most commonly alongside acetaminophen and ibuprofen. In the company’s description, “opioid free” corresponds to not requiring rescue opioids after surgery through the end of treatment. The release presents outcomes spanning opioid-rescue patterns and patient-reported global assessments at end of treatment.

Among patients who received rescue opioids, the release states that nine used rescue medication, with average use of approximately two tablets over two days. The company frames these results as describing postoperative recovery with JOURNAVX used as part of a multimodal approach.

For patient-reported effectiveness, the release identifies the primary endpoint as the proportion of patients rating treatment as excellent, very good, or good on the Patient Global Assessment scale at end of treatment. It reports that 90.7% of patients provided one of these favorable ratings, with a 95% confidence interval of 83.1% to 95.7%. The company presents this result as a summary of how patients categorized overall effectiveness when JOURNAVX was used within the reported perioperative multimodal regimen.

Safety observations in the release describe JOURNAVX as generally safe and well tolerated in this study population. It states that adverse events were mild or moderate in severity and consistent with the postoperative setting, and that there were no serious adverse events related to JOURNAVX. In the company’s summary of the Phase 4 JOURNAVX study, tolerability is characterized in postoperative terms while emphasizing the absence of serious drug-related events as reported.

Key Takeaways:

• The release describes an opioid-rescue pattern in which most participants did not require rescue opioids through the end of treatment, and a small subset used limited rescue medication.
• In the company’s reporting, 90.7% of patients rated treatment effectiveness as excellent, very good, or good on the Patient Global Assessment scale at end of treatment.
• JOURNAVX was described as being used perioperatively within multimodal therapy (often with acetaminophen and ibuprofen), with adverse events characterized as mild/moderate and consistent with the postoperative setting and no serious drug-related events reported.