Pacira BioSciences, Inc. · NASDAQ:PCRX
Pacira BioSciences — Pacira Pharmaceuticals — Technical Presentation (October 2010)
18 slides from Pacira BioSciences's technical presentation, Oct 19, 2010
Slide 1: EXPAREL, A Liposomal Bupivacaine Local Analgesic, Extends Pain Relief and Decreases Opioid Use
EXPAREL™, A Liposomal Bupivacaine Local Analgesic, Extends Pain Relief and Decreases Opioid Use Erol Onel, MD* Howard Miller, MD Gary Patou, MD* Paul F. White, PhD, MD† October 19, 2010 *Employed by Pacira Pharmaceuticals, Inc. †Paid consultant to Pacira Pharmaceuticals, Inc.
Slide 2: EXPAREL DepoFoam Release of bupivacaine
EXPAREL DepoFoam® Release of bupivacaine 2
Slide 3: Injectable Drug: Sustained Release Profile
Injectable Drug: Sustained Release Profile Free Bolus Supratherapeutic Level Sustained-Release Formulation Drug Concentration Minimum Therapeutic Level Time 3
Slide 4: Trial Design
Trial Design 100 patients having hemorrhoidectomy were treated at 8 centers in US and Georgia 26 patients injected 24 patients injected 25 patients injected 25 patients injected with 75mg in 30cc with 75mg in 30cc with 225mg in 30cc with 300mg in 30cc Bupivacaine HCl EXPAREL locally at EXPAREL local
Slide 5: Protocol
Protocol • General or Spinal Anesthesia • Milligan-Morgan or Ferguson technique – Instruments may vary • 2 or 3 column • Excisional Anterior • Internal or Internal/External 5 mL • Cumulative Incision >3cm 5 mL 5 mL Left Right • No Fissurectomy 5 mL 5 mL 5 mL • Double-Blinded Posterior 5
Slide 6: Primary Endpoint
Primary Endpoint • The primary endpoint is the area under the curve (AUC0-72) of the numeric rating scale at rest (NRS-R) pain intensity scores through 72 hours for subjects receiving EXPAREL vs. bupivacaine • To assess: “On a scale of 0-10, where 0 = no pain and 10 = worst possible pain, how much p
Slide 7: Demographics Data
Demographics Data No significant differences among groups 7
Slide 8: Results: Primary Endpoint AUC0-72 of NRS
Results Primary Endpoint: AUC0-72 of NRS 400 *p<0.05 300mg: 46% difference AUC0-72 331 * 200 225 * * 172 175 0 Bupivacaine 75mg EXPAREL 75mg EXPAREL 225mg EXPAREL 300mg 8
Slide 9: NRS Scores
NRS Scores 6 5 NRS 4 * * * 3 * * * * * * * * * * * * * * 2 * * * * * * 1 0 1 2 4 8 12 24 36 48 60 72 84 96 Hours post dose administration Bupiv acaine HCl Expare l 75 Expare l 225 Expare l 300 *p<.05 9
Slide 10: Results: Efficacy Endpoint AUC0-xx
Results Efficacy Endpoint: AUC0-xx *p<0.05 450 400 350 AUC 300 * * * 250 * * * * * 200 * * 150 * * * * 100 ** * * 50 ** * 0 12 24 36 48 60 72 84 96 Hours (AUC from 0 hours through XX hours) Bupivacaine 75 EXPAREL 75 EXPAREL 225 EXPAREL 300 10
Slide 11: Results: Summary of AUC
Results Summary of AUC • The study met its primary endpoint with a statistically significant reduction in AUC0-72 in the patients receiving EXPAREL compared to bupivacaine in each dose: – 75mg: p=0.03 – 225mg: p=0.002 – 300mg: 0=0.002 • AUC showed dose-response with statistical significance at every
Slide 12: Results: Patients with No Opioid Use through 72 hours
Results: Patients with No Opioid Use through 72 hours 40 % 20 0 Bupivacaine 75mg EXPAREL 75mg EXPAREL 225mg EXPAREL 300mg 12
Slide 13: Results: Total Amount of Opioid Use through 72 hours
Results: Total Amount of Opioid Use through 72 hours 20 *p=0.0068 mg 10 * 0 Bupivacaine 75mg EXPAREL 75mg EXPAREL 225mg EXPAREL 300mg 13
Slide 14: Results: Time to First Opioid Use
Results: Time to First Opioid Use 20 * *p=0.0049 hr 10 0 Bupivacaine 75mg EXPAREL 75mg EXPAREL 225mg EXPAREL 300mg 14
Slide 15: Safety: Comparable to Bupivacaine
Safety: Comparable to Bupivacaine Bupivacaine EXPAREL EXPAREL EXPAREL Patients who experienced: 75mg 75mg 225mg 300mg At Least One TEAE 42% 29% 28% 4% Gastrointestinal AE 35% 29% 28% 0% (e.g., PONV) SAE 0% 4% 0% 0% Discontinuation Due to AE 0% 0% 0% 0% Death 0% 0% 0% 0% 15
Slide 16: EXPAREL Showed Decreased Pain, Opioid Use, and Opioid Related AEs
EXPAREL Showed Decreased Pain, Opioid Use, and Opioid Related AEs 300mg EXPAREL vs 75mg Bupivacaine through 72 hours 100% *p<0.05 Compared to Bupivacaine 75mg through 72 hours, EXPAREL 300mg: • Decreased pain by 46% Bupivacaine EXPAREL 300mg 75mg • Decreased opioid use by 57% * 50% • Decreased opioi
Slide 17: Conclusions
Conclusions • A single dose of EXPAREL (75mg, 225mg, and 300mg) administered at the conclusion of the case provided pain control through 72 hours • EXPAREL patients exhibited reduced opioid consumption after surgery – More patients remained opioid-free – Patients required lower total amount of opioi
Slide 18: Thank You
Thank You 18
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