Pacira Pharmaceuticals Inc (NASDAQ:PCRX) announced the publication of its Phase 4 PILLAR study of EXPAREL (bupivacaine liposome injectable suspension) in total knee arthroplasty (TKA). The results, which demonstrate a statistically significant reduction in opioid requirements and pain scores for EXPAREL admixed with bupivacaine HCl versus bupivacaine HCl alone, were published in The Journal of Arthroplasty.
The study’s co-primary efficacy endpoints compared the magnitude and duration of postsurgical analgesia and associated impact on opioid consumption for 139 TKA patients randomized into two groups at 16 centers across the United States. Seventy patients received surgical site infiltration with EXPAREL admixed with bupivacaine HCl; 69 patients received infiltration with bupivacaine HCl alone. Patients in both groups received an identical oral, cost-effective multimodal pain management protocol before and after surgery and had access to rescue opioids as needed. Patients in the EXPAREL arm demonstrated a statistically significant:
- Decrease in total opioid consumption by 78 percent (18.7 mg versus 84.9 mg in the bupivacaine group; P=0.0048) expressed as morphine equivalents from zero to 48 hours after surgery.
- Reduction in pain scores (180.8 versus 209.3 in the bupivacaine group; P=0.0381), measured using the area under the curve of the pain intensity scores measured on a visual analog scale from 12 to 48 hours after surgery.
Importantly, EXPAREL also achieved statistical significance for the study’s key secondary endpoints related to opioid reduction. Patients in the EXPAREL arm required 77.6 percent fewer opioids through 72 hours than those in the bupivacaine arm (20.9 mg versus 93.6 mg, respectively; P=0.0108), with 10 percent remaining opioid-free through 48 and 72 hours (compared to zero patients in the bupivacaine arm; P<0.01). Time to first opioid rescue was analyzed using logistic regression and Kaplan-Meier methods, with a significant difference between the EXPAREL group versus the bupivacaine group; P=0.0230.
EXPAREL and bupivacaine infiltrations both were well tolerated throughout the study duration. The most common treatment-emergent adverse events (TEAEs) in each group were nausea, dizziness and muscle spasms; all were mild to moderate in severity. No patients discontinued the study because of a TEAE.
“The PILLAR study provides robust evidence of the efficacy and safety of EXPAREL as an integral component of multimodal therapy to effectively control pain and substantially reduce, and in some cases completely eliminate, opioid requirements following total knee arthroplasty,” said Michael A. Mont, Chairman of Orthopaedic Surgery at Cleveland Clinicand lead author on the study publication. “These results clearly demonstrate the importance of utilizing a meticulous and standardized infiltration technique on achieving optimal and replicable results for patients.”
In order to ensure consistent results, study investigators utilized a standardized infiltration protocol designed by experienced clinicians. Key features included proper volume expansion to ensure full coverage of the nerve fibers responsible for sending pain signals to the brain, admixing with free bupivacaine to provide sufficient immediate pain relief, and a clear definition of the sites for infiltration and administration technique to ensure adequate coverage of the impacted nerve fibers.
Patients in the EXPAREL group were administered EXPAREL 266 mg/20 mL expanded to a total volume of 120 mL with 20 mL of 0.5% bupivacaine and 80 mL of saline. Patients randomized to receive bupivacaine HCl were administered 20 mL of 0.5% bupivacaine expanded to a total volume of 120 mL with 100 mL of saline. Investigators administered study drug using six 20 mL prefilled syringes.
“We are pleased to present the marketplace with confirmatory data demonstrating the significant positive impact EXPAREL can make on postsurgical recovery by sizably reducing opioid requirements while still providing superior pain control compared to bupivacaine alone,” said Dave Stack, chairman and chief executive officer of Pacira. “In light of the growing body of evidence that connects postsurgical opioids with long-term use, abuse and addiction, this study underscores the importance of EXPAREL as a non-opioid option that can reduce patient exposure to potentially tragic consequences.”
Pacira and its partner in the orthopaedic and spine markets, DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, aim to raise awareness among health care professionals as well as patients of the importance of utilizing alternative options to opioids for postsurgical pain. Collaborative education and commercial efforts will emphasize best practice techniques related to the infiltration of EXPAREL in orthopaedic procedures and the positive outcomes that were obtained for TKA patients where the PILLAR protocol was employed. (Original Source)
Shares of Pacira closed yesterday at $42.65, down $6.05 or -12.42%. PCRX has a 1-year high of $58.95 and a 1-year low of $29.95. The stock’s 50-day moving average is $47.03 and its 200-day moving average is $45.56.
On the ratings front, Pacira has been the subject of a number of recent research reports. In a report released yesterday, Mizuho analyst Irina Rivkind Koffler reiterated a Buy rating on PCRX, with a price target of $54, which implies an upside of 27% from current levels. Separately, on the same day, H.C. Wainwright’s Corey Davis reiterated a Buy rating on the stock and has a price target of $59.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Irina Rivkind Koffler and Corey Davis have a yearly average return of 18.5% and 2.0% respectively. Koffler has a success rate of 55% and is ranked #135 out of 4608 analysts, while Davis has a success rate of 47% and is ranked #1860.
Sentiment on the street is mostly bullish on PCRX stock. Out of 9 analysts who cover the stock, 7 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $61.71, which implies an upside of 45% from current levels.
Pacira Pharmaceuticals, Inc. is a specialty pharmaceutical company. It develops, commercializes, and manufactures pharmaceutical products for use in hospitals and ambulatory surgery centers. It develops pharmaceutical products based on its proprietary DepoFoam drug delivery technology. The company markets EXPAREL, a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia; and DepoCyt(e), a liposomal formulation of the chemotherapeutic agent cytarabine indicated for the intrathecal treatment of lymphomatous meningitis, a cancer of the immune system. Its product pipeline comprise EXPAREL that has completed Phase II clinical trials for postsurgical analgesia-nerve block administration; DepoNSAID, which is in preclinical trials for the relief of that is in preclinical trials acute pain; and DepoTXA is currently in pre-clinical development, which is used to treat or prevent excessive blood loss during surgery by promoting hemostasis.