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Pacira's Exparel Positive in Phase IV Studies

Zacks Equity Research

Pacira Pharmaceuticals, Inc. (PCRX) announced the results of a series of open-label prospective phase IV studies (:IMPROVE) on its pain management drug, Exparel (bupivacaine liposome injectable suspension) in post-surgical patients. The studies (n=191) made a pooled analysis of the data to evaluate the post-surgical narcotic use and pharmacoeconomic benefit of Exparel in comparison to an opioid-based pain management regimen.

Pacira conducted the studies in patients who had undergone three common gastrointestinal surgeries−open colectomy, laparoscopic colectomy and ileostomy reversal.

Results showed that treatment with the Exparel-based multimodal analgesic regimen led to 60% and 67% reduction in total narcotic consumption and incidence of opioid-related adverse events, respectively. The median length of hospital stay was reduced by 1.4 day and resulted in $2,455 savings in mean per-patient hospitalization costs.

We note that Exparel is already approved for administration into the surgical site to produce post-surgical analgesia for up to 72 hours. It was launched in the U.S. in Apr 2012. In 2013, Exparel generated net sales of $76.2 million.

We remind investors that in Mar 2014, the FDA approved an additional bulk manufacturing suite (Suite C) for Exparel at the current manufacturing site in San Diego. Expansion of manufacturing capacity has allowed Pacira to meet the growing market demand for multimodal pain management regimen.

We are pleased to see Pacira’s label expansion efforts for Exparel. Pacira is currently evaluating Exparel for several indications, including nerve block administration. The company filed a supplemental New Drug Application (sNDA) for Exparel for femoral nerve block in total knee arthroplasty patients last month.

We expect investor focus to remain on updates regarding Exparel for femoral nerve block.

Pacira carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP), ARIAD Pharmaceuticals Inc. (ARIA) and Endo International plc (ENDP). While ANI Pharma carries a Zacks Rank #1 (Strong Buy), ARIAD and Endo International hold a Zacks Rank #2 (Buy).

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