Pacira BioSciences has revealed the final results for its drug Exparel (bupivacaine liposome injectable suspension), indicating its efficacy as a sciatic nerve block.
The data, which was published in the Journal of Clinical Anesthesia on 15 February, is from a Phase III trial (NCT05157841) involving 185 patients undergoing a bunionectomy, a surgery to correct bunions.
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Exparel first gained FDA approval as a treatment for post-surgical pain management in 2011, going on to receive approval as a nerve block to produce regional analgesia or pain relief in 2018. The FDA then went on to approve the expanded Exparel label to include its use as a sciatic nerve block in the popliteal fossa or knee joint, as well as an adductor canal block—a neurovascular canal in the thigh— in November 2023.
The Phase III bunionectomy trial had successfully met its primary endpoint, with statistically significant and superior pain control for four days post-surgery, including a 44% difference in pain scores through 96 hours.
Moreover, patients receiving Exparel 133mg—the approved dose— in the popliteal fossa after a bunionectomy consumed 61% fewer opioids through 96 hours compared to those receiving local anaesthetic bupivacaine, fulfilling the secondary endpoint of reduced opioid consumption. Additionally, almost 25% of the patients did not require rescue opioids for the first four days after surgery, when treated with Exparel compared to 6% in the bupivacaine group.
According to GlobalData’s Pharma Intelligence Center, Exparel is forecast to generate $877m globally in 2029. In 2022, the drug earned $537m, as per Pacira’s full-year financial results.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Investigating drugs that can reduce opioid consumption is significant due to the ongoing opioid crisis going on in the US. Opioid medications bind to specific receptors in the brain that reduce the perception of pain while also producing feelings of euphoria, relaxation, and sedation, making the drugs addictive, and potentially leading to dependence with prolonged use.
In the announcement accompanying the data, Pacira CEO Frank Lee emphasised the importance of non-opioid pain relief: “Importantly, the use of EXPAREL as a sciatic nerve block in the popliteal fossa affords clinicians additional flexibility in their opioid-sparing pain management approaches for foot and ankle procedures, which continue to migrate to the outpatient environment where success is predicated on the ability to provide appropriate pain control without the need for a significant opioid burden.”
Earlier this year, Vertex Pharmaceuticals announced plans to submit a new drug application (NDA) to the FDA following positive Phase III trial results investigating its non-opioid pain drug.
