Multicenter study in patients undergoing ileostomy reversal reinforces results from first IMPROVE study in open colectomy
PARSIPPANY, NJ, USA I July 18, 2013 I Pacira Pharmaceuticals, Inc. (PCRX) today announced that results from the second IMPROVE study to complete its prospective Phase 4 clinical program were published in the online version of the Journal of Pain Research. The IMPROVE studies assess the differences in postsurgical opioid use and health economic outcomes between patients receiving EXPAREL® (bupivacaine liposome injectable suspension) as the foundation of an opioid-sparing multimodal regimen versus a standard opioid-based analgesic regimen.
All study patients underwent ileostomy reversal, a surgery performed to reconnect a section of small intestine. Compared to patients in the standard opioid-based treatment arm, patients undergoing the same procedure and receiving an EXPAREL-based multimodal regimen had:
- A 2.1 day reduction in median length of hospital stay (3.0 days in the EXPAREL group compared to 5.1 days in the IV opioid-based PCA group, respectively; P
- A $2,800 reduction in mean hospitalization costs ($6,482 in the EXPAREL group compared with $9,282 in the IV opioid-based PCA group, respectively; P
- A 92 mg reduction in mean opioid consumption (20 mg in the EXPAREL group compared with 112 mg in the IV opioid-based PCA group, respectively; P
“Gastrointestinal motility complications such as intestinal blockages are common following ileostomy reversal, and can be triggered or exacerbated by the use of opioids during and after surgery,” said Jorge E. Marcet, M.D., the study’s lead author and professor and division director of colon and rectal surgery at Morsani College of Medicine, University of South Florida. “In these patients, an opioid-sparing multimodal regimen using EXPAREL was shown to significantly reduce opioid intake, enable earlier discharge and lower the associated costs of care compared to a standard opioid-based pain management strategy.”
The study evaluated 27 adult patients who underwent planned ileostomy reversal procedures at three U.S. sites. Sixteen patients were enrolled in the EXPAREL-based multimodal group; 11 patients were enrolled in the opioid-based group.
The current study is the second in a series of open-label Phase 4 studies known as IMPROVE. In November 2012, the first IMPROVE study was published in the Journal of Pain Research and demonstrated similar positive outcomes associated with using EXPAREL in patients who underwent open colectomy.
“Continuing to demonstrate clinically meaningful benefits of EXPAREL, such as shorter length of stay and lower hospital costs, is critical to reinforcing the value of the product to the surgical community and hospital administrators,” said Dave Stack, president, chief executive officer and chairman of Pacira Pharmaceuticals, Inc. “With patient-reported surveys such as HCAHPS impacting reimbursement payments, hospitals are placing a growing emphasis on improving patient satisfaction and quality of care. The IMPROVE studies, which demonstrate measurable advantages when using an EXPAREL-based multimodal regimen compared to an opioid-based approach, may prompt a shift towards an opioid-sparing pain management model.”
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first national, standardized, publicly reported survey measuring and comparing patients’ perceptions of their hospital experiences, including satisfaction with pain control. Since October 2012, HCAHPS performance scores are now being used to calculate a portion of a hospital’s value-based incentive payment from the Centers for Medicare & Medicaid Services.1
The full IMPROVE ileostomy reversal study publication is available online here: http://www.dovepress.com/an-extended-pain-relief-trial-utilizing-the-infiltration-of-a-long-act-peer-reviewed-article-JPR
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
About Pacira
Pacira Pharmaceuticals, Inc. (PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
SOURCE: Pacira Pharmaceuticals
Post Views: 180
Multicenter study in patients undergoing ileostomy reversal reinforces results from first IMPROVE study in open colectomy
PARSIPPANY, NJ, USA I July 18, 2013 I Pacira Pharmaceuticals, Inc. (PCRX) today announced that results from the second IMPROVE study to complete its prospective Phase 4 clinical program were published in the online version of the Journal of Pain Research. The IMPROVE studies assess the differences in postsurgical opioid use and health economic outcomes between patients receiving EXPAREL® (bupivacaine liposome injectable suspension) as the foundation of an opioid-sparing multimodal regimen versus a standard opioid-based analgesic regimen.
All study patients underwent ileostomy reversal, a surgery performed to reconnect a section of small intestine. Compared to patients in the standard opioid-based treatment arm, patients undergoing the same procedure and receiving an EXPAREL-based multimodal regimen had:
- A 2.1 day reduction in median length of hospital stay (3.0 days in the EXPAREL group compared to 5.1 days in the IV opioid-based PCA group, respectively; P
- A $2,800 reduction in mean hospitalization costs ($6,482 in the EXPAREL group compared with $9,282 in the IV opioid-based PCA group, respectively; P
- A 92 mg reduction in mean opioid consumption (20 mg in the EXPAREL group compared with 112 mg in the IV opioid-based PCA group, respectively; P
“Gastrointestinal motility complications such as intestinal blockages are common following ileostomy reversal, and can be triggered or exacerbated by the use of opioids during and after surgery,” said Jorge E. Marcet, M.D., the study’s lead author and professor and division director of colon and rectal surgery at Morsani College of Medicine, University of South Florida. “In these patients, an opioid-sparing multimodal regimen using EXPAREL was shown to significantly reduce opioid intake, enable earlier discharge and lower the associated costs of care compared to a standard opioid-based pain management strategy.”
The study evaluated 27 adult patients who underwent planned ileostomy reversal procedures at three U.S. sites. Sixteen patients were enrolled in the EXPAREL-based multimodal group; 11 patients were enrolled in the opioid-based group.
The current study is the second in a series of open-label Phase 4 studies known as IMPROVE. In November 2012, the first IMPROVE study was published in the Journal of Pain Research and demonstrated similar positive outcomes associated with using EXPAREL in patients who underwent open colectomy.
“Continuing to demonstrate clinically meaningful benefits of EXPAREL, such as shorter length of stay and lower hospital costs, is critical to reinforcing the value of the product to the surgical community and hospital administrators,” said Dave Stack, president, chief executive officer and chairman of Pacira Pharmaceuticals, Inc. “With patient-reported surveys such as HCAHPS impacting reimbursement payments, hospitals are placing a growing emphasis on improving patient satisfaction and quality of care. The IMPROVE studies, which demonstrate measurable advantages when using an EXPAREL-based multimodal regimen compared to an opioid-based approach, may prompt a shift towards an opioid-sparing pain management model.”
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first national, standardized, publicly reported survey measuring and comparing patients’ perceptions of their hospital experiences, including satisfaction with pain control. Since October 2012, HCAHPS performance scores are now being used to calculate a portion of a hospital’s value-based incentive payment from the Centers for Medicare & Medicaid Services.1
The full IMPROVE ileostomy reversal study publication is available online here: http://www.dovepress.com/an-extended-pain-relief-trial-utilizing-the-infiltration-of-a-long-act-peer-reviewed-article-JPR
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
About Pacira
Pacira Pharmaceuticals, Inc. (PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
SOURCE: Pacira Pharmaceuticals
Post Views: 180
