Pacira ((PCRX)) announced an update on their ongoing clinical study.
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Pacira Pharmaceuticals is conducting a study titled ‘A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery.’ The study aims to assess the pharmacokinetics and safety of EXPAREL, a local infiltration analgesic, compared to bupivacaine in young pediatric patients post-cardiac surgery. This research is significant as it explores pain management solutions for a vulnerable age group.
The study tests two interventions: EXPAREL, an experimental drug, and bupivacaine, an active comparator. Both are administered as a single dose via local infiltration analgesia (LIA) to manage postoperative pain.
This Phase 1 study is interventional with a randomized allocation and a single-group intervention model. There is no masking involved, and the primary purpose is treatment-focused, aiming to provide insights into effective pain management for young children post-surgery.
The study began on January 18, 2024, with its primary completion and estimated completion dates yet to be announced. The most recent update was submitted on October 15, 2025, indicating ongoing recruitment and data collection.
The outcome of this study could significantly impact Pacira’s market position, particularly if EXPAREL proves to be a safer and more effective alternative to bupivacaine. This could enhance investor confidence and potentially boost stock performance, especially in comparison to competitors in the pediatric analgesia market.
The study is currently ongoing, with further details available on the ClinicalTrials portal.