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Pacira's Study on Exparel Label Expansion Meets Endpoints

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Shares of Pacira Pharmaceuticals, Inc. (PCRX - Free Report) went up 2.62% after the company announced that the phase IV study on its lead drug Exparel in patients undergoing Cesarean section (C-section) achieved its primary endpoint, with a statistically significant reduction in total postsurgical opioid consumption through 72 hours (P≤0.05).

Exparel also achieved statistical significance for reduction in pain intensity through 72 hours. Shares of the company have declined 4.9% in the past year compared with the industry’s decline of 19.8%.

We remind investors that Exparel is a liposome injection of bupivacaine, which is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. In June 2018, the FDA also approved Exparel label to include administration via nerve block for prolonged regional analgesia. With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.

The study also achieved statistical significance for relevant additional endpoints pre-specified in the statistical analysis plan to better characterize the clinical benefit of the opioid reduction, includingtotal opioid consumption at one and two weeks, following C-section and percentage of opioid-spared patients, which was the composite endpoint.

In the study, patients undergoing elective C-section and given spinal anesthesia were randomized to receive Exparel or the active comparator bupivacaine HCl. Patients in the Exparel arm were administered a transversus abdominis plane (TAP) field block with 10 mL Exparel admixed with 10 mL 0.25% bupivacaine HCl and 10 mL normal sterile saline injected bilaterally. Patients in the active comparator arm received a TAP field block with 10 mL 0.25% bupivacaine HCl admixed with 20 mL normal sterile saline injected bilaterally.

The study showed that when added to the standard of care, an Exparel TAP block provided a superior long-acting field block that not only adequately controlled patients’ pain following C-section, but also greatly reduced their need for opioids.

The company is also conducting a phase IV study of Exparel in spinal fusion surgery. The company is also launching a series of phase IV studies in soft tissue procedures. These studies will assess Exparel as part of its multimodal protocol for colon cancer and breast reconstruction surgery.

The company’s efforts to expand Exparel's label to boost sales are encouraging.

Exparel sales were $82.2 million in the third quarter of 2018, rising 23% year over year.

Zacks Rank and Stocks to Consider

Pacira currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks worth considering are Merck & Co., Inc. (MRK - Free Report) , AbbVie Inc. (ABBV - Free Report) and Eli Lilly and Co. (LLY - Free Report) . While Merck sports a Zacks Rank #1 (Strong Buy), AbbVie and Lilly carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merck’s earnings per share estimates have increased from $4.28 to $4.33 for 2018 and from $4.65 to $4.69 for 2019 over the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 3.96%.

AbbVie’s earnings per share estimates have increased from $7.86 to $7.93 for 2018 and over the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 3.54%.

Lilly’s earnings per share estimates have increased from $5.47 to $5.58 for 2018 and from $5.78 to $5.87 for 2019 over the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 10.03%.

 

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