Additional Data on Pacira's Exparel - Analyst Blog

Pacira Pharmaceuticals, Inc. PCRX announced additional phase III data on its lead product, Exparel. Pacira is looking to expand Exparel's label. Exparel is being evaluated as a femoral nerve block in total knee arthroplasty patients.

Data supporting the efficacy and safety of Exparel was presented at the 39th Annual Meeting of the American Society of Regional Anesthesia and Pain Medicine.

The phase III study evaluated patients who received either a femoral nerve block with Exparel or a placebo. At day 7, 55% of the patients were satisfied with pain control in the Exparel group as compared to 43% in the placebo arm. At 60 hours, 50% of the patients were pain-free in the Exparel group (statistically significant) as compared to 40% in the placebo arm. The Exparel group also showed 24% reduction in total opioid use.

Earlier, on Feb 27, 2014, the company had announced the primary endpoint results on Exparel as a femoral nerve block in total knee arthroplasty patients. The study met its primary endpoint of statistically significant reduction in cumulative pain scores over 72 hours compared to placebo.

Pacira expects to submit a supplemental New Drug Application (sNDA) as a femoral nerve-block in total knee arthroplasty patients in the second quarter of 2014.

We note that Exparel is approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce post-surgical analgesia. The drug was launched in Apr 2012. Net Exparel revenues were $76.2 million in 2013.

We expect investor focus to remain on the sNDA submission of Exparel as a femoral nerve block in total knee arthroplasty patients. Pacira carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the pharma sector may consider companies like Impax Laboratories Inc. IPXL, Actavis plc ACT and Lannett Co., Inc. LCI. Actavis and Impax Labs carry a Zacks Rank #2 (Buy) while Lannett carries a Zacks Rank #1 (Strong Buy).