|Pacira Announces Topline Phase 3 Results for EXPAREL® as a Single-dose Nerve Block|
Upper extremity study showed that EXPAREL significantly reduces pain scores and opioid use
Lower extremity study defined safety and pharmacokinetic profile through 120 hours
Timing for resubmission of supplemental New Drug Application remains on track
Conference call scheduled for today at
“These new data add to the growing body of evidence supporting EXPAREL in the nerve block setting,” said
Upper Extremity Study
EXPAREL demonstrated statistical significance for the primary endpoint of cumulative pain scores over 48 hours as measured by the area under the curve (p<0.0001). EXPAREL also achieved statistical significance versus placebo for the study’s key secondary endpoints as follows: total postsurgical opioid consumption through 48 hours (p<0.0001); opioid-free subjects through 48 hours (p<0.01); and time to first opioid rescue through 48 hours (p<0.0001).
The study randomized 156 patients across 17 sites in a 1:1 ratio to receive a single dose of either EXPAREL 133 mg in 10 mL expanded in volume with 10 mL of normal saline for a total volume of 20 mL or placebo 20 mL. EXPAREL was administered as a single-dose brachial plexus block under ultrasound guidance at least one hour prior to surgery. All patients were eligible to receive postsurgical rescue opioids upon request for pain control.
The study captured pharmacokinetic data through 120 hours to determine the median time to maximum plasma concentration (Tmax) for EXPAREL.
The preliminary safety analysis was consistent with previously reported studies of brachial plexus nerve blocks with bupivacaine.
Lower Extremity Study
EXPAREL did not demonstrate statistical significance in the femoral nerve block study (p>0.05) due to a significant deviation from protocol identified at a single center. When these patients were excluded from the analyses, patients receiving 266 mg EXPAREL achieved statistical significance versus placebo for the study’s primary endpoint of cumulative pain scores over 72 hours as measured by the area under the curve (p<0.03).
The study randomized 232 patients across 14 sites in a 1:1:1 ratio to receive a single dose of either EXPAREL 133 mg in 10 mL expanded in volume with 10 mL of normal saline for a total volume of 20 mL; EXPAREL 266 mg in 20 mL; or placebo 20 mL. Study drug was administered as a single-dose femoral nerve block under ultrasound guidance at least one hour prior to surgery. In addition to study drug, prior to placement of the prosthesis, 8 mL of bupivacaine HCl (0.5%) diluted with 8 mL of normal saline was administered as a periarticular infiltration to the posterior capsule of the knee. All patients were eligible to receive postsurgical rescue opioids upon request for pain control.
The study captured pharmacokinetic data through 120 hours to determine the median time to Tmax for EXPAREL.
The preliminary safety analysis was consistent with previously reported studies of femoral nerve blocks with bupivacaine.
Nerve Block Development Program
In 2014, Pacira submitted a supplemental New Drug Application (sNDA) to the
In 2015, the company received a complete response letter (CRL) from the
The company believes the results from these studies will support the resubmission of its sNDA to the
Pacira plans to submit the full results from the Phase 3 studies for presentation at future scientific conferences and for publication in peer-reviewed journals.
The Pacira management team will host a call today at
The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
EXPAREL (bupivacaine liposome injectable suspension) is currently 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 period of time. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. 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.
Please see the full Prescribing Information for more details available at:
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and our other products; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of