Ph III data shows Pacira’ Exparel good as femoral nerve block in knee arthroplasty

US drugmaker Pacira Pharmaceuticals (Nasdaq: PCRX) has released additional Phase III data supporting the efficacy and safety of Exparel (bupivacaine liposome injectable suspension) to achieve femoral nerve block in patients undergoing total knee arthroplasty.

The company previously announced results of the primary efficacy endpoint, a statistically significant reduction in cumulative pain scores over 72 hours compared to placebo (P<0.0001). Secondary endpoints presented at the 39th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA) found that a higher percentage of patients who received Exparel were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control.

As a result the positive new findings, Pacira plans to file a supplemental New Drug Application for this indication with the US Food and Drug Administration in the second quarter of the current year. Just last month, the FDA approved an additional bulk manufacturing suite for Exparel, which the company said would enable it to meet growing demand for the product, which was commercially launched in the USA in April 2012.