|Pacira Pharmaceuticals, Inc. Announces Positive Interim Analysis of EXPAREL in Femoral Nerve Block for Total Knee Arthroplasty|
Completed Dose Ranging Portion of Pivotal Nerve Block Trial; Phase 3 Initiating; sNDA on Track for Early 2014
“We are pleased with the interim analysis of the safety and efficacy of
EXPAREL in this important orthopedic indication,” said
Designed as a two-part study, the first part of this double-blind, placebo-controlled trial evaluated the safety and efficacy of three doses of EXPAREL in 100 total patients to identify a single therapeutic dose for further investigation. A total of 100 patients received a femoral nerve block prior to TKA of 67 mg, 133 mg or 266 mg of EXPAREL or placebo (25 patients per group). Based on the evaluation of both safety and efficacy after 72 hours of follow-up, a single dose level was to be selected for assessment in the second part of the study. Following the review of the data, the committee responsible for assessing the safety and efficacy profile determined that EXPAREL should be dosed at 266 mg in the Phase 3 portion of the study, which will be initiated shortly. The committee also confirmed that if results from the Phase 2 portion of the trial are replicated in Phase 3, the target enrollment of 180 patients should be adequate to demonstrate the safety and efficacy of the indication.
In the Phase 3 portion of the study, those 180 patients will receive either 266 mg of EXPAREL or placebo as a femoral nerve block (90 randomized to each arm). In addition to pharmacokinetic and safety data, multiple efficacy endpoints will be measured.
In addition, Pacira also reported today that patient enrollment was
completed in a second Phase 3 nerve block clinical trial. This
double-blind, placebo-controlled intercostal nerve block study enrolled
180 patients (90 patients on each arm) who were undergoing thoracotomy.
The Company expects that results from this additional Phase 3 study will
contribute to a planned
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.
Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about our plans and
expectations regarding EXPAREL, and other statements containing the
words “believes,” “anticipates,” “plans,” “expects,” 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; the size and growth of the potential
markets for EXPAREL and our ability to serve those markets; our plans to
expand the indications of EXPAREL to include nerve block; our plans to
continue to manufacture and provide support services for our commercial
partners who have licensed DepoCyt(e); our commercialization and
marketing capabilities; and other factors discussed in the “Risk
Factors” of our most recent Annual Report on Form 10-K for the fiscal
Pacira Pharmaceuticals, Inc.