Pacira BioSciences, Inc. · NASDAQ:PCRX
Pacira BioSciences — Pacira Pharmaceuticals — Technical Presentation (October 2010)
20 slides from Pacira BioSciences's technical presentation, Oct 9, 2010
Slide 1: EXPAREL delays time to first opioid and reduces opioid requirements after hemorrhoidectomy
EXPAREL™, an investigational extended-release liposome injection of bupivacaine, delays time to first opioid and reduces opioid requirements for three days after hemorrhoidectomy Erol Onel, MD* Kay Warnott, RN, ACNP-A* Baadur Mosidze, MD, PhD Adam Dziki, MD Gary Patou, MD* Zoran Krivokapic, MD Octob
Slide 2: Injectable Drug: Release Profile
Injectable Drug: Release Profile Free Bolus Supratherapeutic Level Drug Concentration Minimum Therapeutic Level Time 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: DepoFoam Multivesicular Liposomes
DepoFoam® Multivesicular Liposomes Scanning Electron Microscopy image 4
Slide 5: EXPAREL DepoFoam Release of bupivacaine
EXPAREL DepoFoam Release of bupivacaine 5
Slide 6: Trial Design
Trial Design 189 patients having Milligan-Morgan hemorrhoidectomy were treated at 12 centers in Poland, Georgia, and Serbia; 25% patients also in nested pk study 95 patients injected with 300mg in 30cc 94 patients injected with 30cc EXPAREL locally at conclusion of case placebo locally at conclusion
Slide 7: Sites
Sites EUROPE ado mu SE PACIRA hic Research Lab niversity of Alabama Produced by the Gartograp 7 A PASSION FOR DELIVERING IMPROVED PATIENT CARE™
Slide 8: Demographics: Well Matched
Demographics: Well Matched EXPAREL 300mg Placebo (n=95) (n=94) Age (Mean) 48.0y 48.7y Male 66.3% 71.3% Female 33.7% 28.7% Race American Indian or Alaska Native 0% 0% Asian 0% 0% Black or African American 0% 0% White or Caucasian 100% 100% Ethnicity Hispanic or Latino 0% 0% Not Hispanic or Latino 100
Slide 9: Protocol
Protocol • General Anesthesia • Milligan-Morgan technique – Instruments may vary • 2 or 3 column • Excisional • Internal or Internal/External Anterior • Cumulative Incision >3cm 5 mL • No Fissurectomy Left 5 mL 5 mL Right 5 mL 5 mL • Double-Blinded 5 mL Posterior 9
Slide 10: 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. placebo • To assess: “On a scale of 0-10, where 0 = no pain and 10 = worst possible pain, how much pain
Slide 11: Results: Primary Endpoint - AUC0-72 of NRS
Results: Primary Endpoint - AUC0-72 of NRS *p<0.0001 300 ~30% Difference AUC0-72 200 * 202 100 142 0 Placebo EXPAREL 300mg 11
Slide 12: Results: Summary
Results: Summary • The study met its primary endpoint with a statistically significant reduction in AUC0-72 in the subjects receiving EXPAREL compared to placebo (p<0.0001) • The difference was statistically significant at p<0.0001 at every tested timepoint from 0 hours to 72 hours (12, 24, 36, 48,
Slide 13: Results: AUC Through Different Timepoints
Results: AUC Through Different Timepoints *p<0.0001 * AUC 200 * 0-xx * 150 * * 100 * 50 0 12h 24h 36h 48h 60h 72h Placebo EXPAREL 300mg 13
Slide 14: Median Time to First Opioid
Median Time to First Opioid: 1h 10m vs 14hr 20m 100% 75% *p<0.0001 50% 25% 0% 2h 4h 8h 12h 24h 36h 48h 60h 72h Placebo EXPAREL 300mg 14
Slide 15: Patients Avoiding Opioids (%)
Patients Avoiding Opioids (%): 14 vs 59 at 12h; 10 vs 28 at 72h *p<0.0008 100 75 * % 50 * * * * * 25 0 12h 24h 36h 48h 60h 72h Placebo EXPAREL 300mg 15
Slide 16: Total Opioid Consumption (mg)
Total Opioid Consumption (mg): 15 vs 6 at 12h; 29 vs 22 at 72h *p<0.0007 30 * * * Mean mg MS * * 20 * 10 0 12h 24h 36h 48h 60h 72h Placebo EXPAREL 300mg 16
Slide 17: Safety: Equivalent to Placebo
Safety: Equivalent to Placebo Patients who experienced: Placebo EXPAREL At Least One TEAE 18% 17% At Least One Related TEAE 0% 1% Gastrointestinal AE (e.g., PONV) 14% 8% SAE 1% 0% Discontinuation Due to AE 0% 0% Death 0% 0% 17
Slide 18: Benefits of a Non Opioid Platform
Benefits of a Non Opioid Platform • Decreased opioid-related side effects – Nausea, vomiting, constipation, urinary retention, pruritis, somnolence, respiratory depression • Decreased hospital resource consumption – Time from PACU to floor – Nursing time to monitor opioid-related side effects and PC
Slide 19: Conclusions
Conclusions • EXPAREL provided pain control out to 72 hours • Reduced opioid consumption – Patients needed fewer opioids – More patients remained opioid free – Patients stayed off opioids until later in hospitalization • Safety equivalent to placebo EXPAREL has the potential to offer clinically mean
Slide 20: Hvala (Thank You)
Hvala (Thank You) 20
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