EXPAREL vs bupivacaine HCl in TKA (adductor canal pivotal trial)1
Superior pain control and reduced opioid consumption through 4 days vs bupivacaine HCl
Superior
PAIN CONTROL
vs bupivacaine HCl
cumulative pain scores
(P<0.0074)
23%
FEWER OPIOIDS*
total postsurgical opioid consumption
(P<0.0071)
Significantly better pain control vs bupivacaine HCl postsurgery on2:
DAY 2
(P=0.0018)DAY 3
(P=0.0191)DAY 4
(P=0.0404)*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
The adductor canal block pivotal trial investigated EXPAREL admixed with bupivacaine HCI versus bupivacaine HCl alone, administered as an adductor canal block (ACB) for total knee arthroplasty (TKA). Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl OR 50 mg (10 mL) of 0.5% bupivacaine HCl mixed with 10 mL normal saline via saphenous nerve (adductor canal) block. All patients also received 37.5 mg (15 mL) of 0.25% immediate-release bupivacaine HCl as an infiltration between the popliteal artery and capsule of the knee (IPACK) block immediately following study drug administration.
EXPAREL vs bupivacaine HCI in TKA3
78%
FEWER OPIOIDS
overall opioid consumption
P<0.005
Significantly better
PAIN CONTROL
cumulative pain scores
P<0.04
1 out of 10 patients who received EXPAREL was opioid-free
10% with
exparel
vs
(P<0.01)0% WITH
BUPIVACAINE
HCI
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
Results from a phase 4, double-blind, randomized, controlled trial that compared the efficacy and safety of EXPAREL 266 mg (20 mL) (n=70) and bupivacaine HCl (n=69) in a TKA study. Primary end points: area under the curve (AUC) of visual analog scale pain intensity scores 12 to 48 hours postsurgery; total opioid consumption 0 to 48 hours postsurgery. Rescue opioids for pain were available upon patient request. Rates and types of adverse events were similar between treatment groups. The most common adverse events were nausea, dizziness, and muscle spasms.
EXPAREL vs bupivacaine HCl in foot and ankle surgery (sciatic nerve block in the popliteal fossa pivotal trial)4
Superior pain control and reduced opioid consumption through 4 days vs bupivacaine HCl
Superior
PAIN CONTROL
vs bupivacaine HCl
cumulative pain scores
P<0.00001
61%
FEWER OPIOIDS*
total postsurgical opioid consumption
P<0.00001
5x more participants in the EXPAREL group were opioid free through 4 days
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
The sciatic nerve block in the popliteal fossa pivotal trial investigated EXPAREL versus bupivacaine HCl administered via sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy, a common and well-validated surgical model often used to study postsurgical pain for foot and ankle procedures. Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL mixed with 20 mL saline OR 50 mg (20 mL) of 0.25% bupivacaine HCl mixed with 10 mL saline via sciatic nerve block in the popliteal fossa. All patients received 100 mg (20 mL) of 0.5% immediate-release bupivacaine HCl as a Mayo field block after study drug administration
EXPAREL vs placebo in ISBP nerve block for total shoulder arthroplasty and rotator cuff repair study5†
78%
FEWER OPIOIDS
overall opioid consumption
P<0.0001
Significantly better
PAIN CONTROL
cumulative pain scores
P<0.0001
Significantly more patients were opioid-free with EXPAREL
23% AT 24 HOURS
P<0.0001AND
13% AT 48 HOURS
P=0.008*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
†Rescue opioids for pain were available upon patient request.
Results from a phase 3, multicenter, controlled trial that compared the postsurgical analgesia efficacy, safety, and pharmacokinetics of EXPAREL 133 mg (10 mL) and placebo in patients undergoing total shoulder arthroplasty or rotator cuff repair. Primary and secondary end points: pain intensity through 48 hours postsurgery, as measured by AUC of VAS pain intensity scores, and total postsurgical opioid consumption.
EXPAREL vs placebo in hemorrhoidectomy6,7
Significantly lower
OPIOID USE*
45% lower overall
opioid consumption
P=0.0006‡
Significantly better
PAIN CONTROL
30% lower cumulative
pain scores
P<0.0001‡
3 out of 10 patients who received EXPAREL were opioid-free6
28% with
exparel
vs
(P<0.0008)10% WITH
PLACEBO
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
‡Results vs placebo through 72 hours. Opioid reduction calculated based on geometric mean ratio.
Results from a phase 3, multicenter, randomized double-blind, placebo-controlled trial that evaluated the efficacy of 166 mg (20 mL) of EXPAREL in 186 patients undergoing 2- or 3-column excisional hemorrhoidectomy. Primary end point: cumulative pain score reflected in AUC of numeric rating scale through 72 hours. Placebo was preservative-free saline for injection. Opioid rescue medication (up to 10 mg) of morphine administered intramuscularly) was available to all patients.
EXPAREL TAP block vs bupivacaine TAP block in C-section study8
52%
FEWER OPIOIDS at 72 hours
overall opioid consumption
P<0.0117§
Comparable
PAIN CONTROL
through 72 hours
overall opioid consumption
Results from a prospective, 13-site, multicenter, randomized clinical trial, EXPAREL significantly improved postsurgical recovery when used in a TAP block after C-section. Primary end point: EXPAREL reduced opioid consumption by 52%, compared with standard bupivacaine, over 72 hours and maintained a significant opioid-minimizing effect over 2 weeks.
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
§The reduction in opioid consumption continued for two weeks postpartum.
AUC, area under the curve; ISBP, interscalene brachial plexus; TAP, transversus abdominis plane; TKA, total knee arthroplasty; VAS, Visual Analogue Scale.
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.
