Pacira Pharmaceuticals, Inc.
) 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
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
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.
ARIAD Pharmaceuticals Inc.
Endo International plc
). While ANI Pharma carries a Zacks Rank #1 (Strong Buy), ARIAD and
Endo International hold a Zacks Rank #2 (Buy).
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