Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Technical Presentation (2017)
13 slides from Heron Therapeutics's technical presentation, 2017
Slide 1: HTX-011 Reduces Acute Postoperative Pain Intensity and Opioid Consumption Following Bunionectomy
HTX-011, a Proprietary, Unique, Long-Acting Local Anesthetic, Reduces Acute Postoperative Pain Intensity and Opioid Consumption Following Bunionectomy Eugene Viscusi,1 Oscar DeLeon-Casasola,2 TJ Gan,3 Erol Onel,4 Guy Boccia,4 Alice Chu,4 Mary Rose Keller,4 Thomas Ottoboni,4 Sanjay S Patel,4 Barry Qu
Slide 2: Disclosures
Disclosures • Erol Onel is an employee of Heron Therapeutics, Inc. 2
Slide 3: HTX-011, a Novel, Long-Acting Local Analgesic for Non-Opioid Postoperative Pain Management
HTX-011, a Novel, Long-Acting Local Analgesic for Non-Opioid Postoperative Pain Management Postoperative Pain and the Opioid Crisis • Overreliance on opioids for postoperative pain can lead to increased: − Risk of opioid-related adverse events for patients1 − Costs for hospitals2 − Societal impact o
Slide 4: HTX-011 is Ideally Suited for Needle-Free Administration
Although it Can Be Injected Like Bupivacaine, HTX-011 is Ideally Suited for Needle-Free Administration • HTX-011 is easy to apply and stays in place at the surgical site after application • HTX-011 releases its active ingredients simultaneously • HTX-011’s release is controlled by diffusion from the
Slide 5: Bunionectomy Study: Phase 2 Clinical Study Design
Bunionectomy Study: Phase 2 Clinical Study Design Screening Study Treatments Key Inclusion Criteria HTX-011 200 mg Bupivacaine HCl 50 mg • Male or female ≥18 years old • Able to undergo a lidocaine Mayo block for HTX-011 120 mg Saline Placebo primary unilateral first metatarsal bunionectomy repair H
Slide 6: Baseline Demographics and Characteristics Comparable Across Cohorts
Bunionectomy Study: Baseline Demographics and Characteristics Comparable Across Cohorts HTX-011 Bupivacaine HCl Bupivacaine ER Saline Meloxicam ER 60 mga 50 mg 60 mg Placebo n = 30 n = 52 n = 25 n = 23 n = 104b Female, n (%) 45 (86.5) 22 (88.0) 21 (91.3) 27 (90.0) 91 (87.5) Male, n (%) 7 (13.5) 3 (1
Slide 7: HTX-011 Significantly Reduced Pain Compared with Bupivacaine or Saline Placebo Through 72 Hours
Bunionectomy Study: HTX-011 Significantly Reduced Pain Compared with Bupivacaine or Saline Placebo Through 72 Hours HTX-011 60 mg (n = 52) Bupivacaine HCl 50 mg (n = 25) Saline Placebo (n = 103) 10 9 Severe Pain Mean Pain Intensity (NRSa) 8 7 6 5 4 3 AUC0-24 AUC0-48 AUC0-72 2 60 mg v P: p < 0.0001 6
Slide 8: Significantly Reduced Pain Through 72 Hours Compared with Bupivacaine
Bunionectomy Study: HTX-011 60 mg Significantly Reduced Pain Through 72 Hours Compared with Bupivacaine HTX-011 60 mg (n = 52) Bupivacaine HCl 50 mg (n = 25) 0 AUCa LSMD (vs Saline Placebo) Greater Pain Reduction -20 -40 -60 p = 0.0020 -80 -100 p = 0.0020 p = 0.0166 -120 0-24 0-48 0-72 Time Interval
Slide 9: HTX-011 Significantly Reduced the Use of Opioid Medication Through 72 Hours
Bunionectomy Study: HTX-011 Significantly Reduced the Use of Opioid Medication Through 72 Hours Compared with Bupivacaine or Saline Placebo HTX-011 60 mg (n = 52) Bupivacaine HCl 50 mg (n = 25) Saline placebo (n = 103) Mean Opioid Rescue Medication, MME 50 p = 0.0047 p = 0.0382 40 p = 0.0002 p = 0.0
Slide 10: HTX-011 Significantly Increased the Proportion of Opioid-Free Subjects
HTX-011 Significantly Increased the Proportion of Opioid-Free Subjects vs Saline Placebo 0-72 Hours After Study Drug Administration Proportion of Opioid-free Subjects, % p = 0.0106 p = 0.4877 HTX-011 60 mg Bupivacaine HCl 50 mg Saline placebo (n = 52) (n = 25) (n = 103) 10
Slide 11: Bunionectomy Study: Summary of TEAEs
Bunionectomy Study: Summary of TEAEs TEAEs Occurring in >10% of Subjects in Any Group, n (%) HTX-011 Bupivacaine HCl Saline 60 mg 50 mg Placebo (n = 52) (n = 25) (n = 104) At least one TEAE 33 (63.5%) 20 (80.0%) 76 (73.1%) Nausea 16 (30.8%) 11 (44.0%) 44 (42.3%) Vomiting 8 (15.4%) 5 (20.0%) 27 (26.0
Slide 12: A Synergistic Effect on Pain Reduction Was Observed with HTX-011
Bunionectomy Study: A Synergistic Effect on Pain Reduction Was Observed with HTX-011 HTX-011 60 mg (n = 52) Bupivacaine ER 60 mg (n = 23) Meloxicam ER (n = 30) 20 AUCa LSMD (vs Saline Placebo) 0 Greater Pain Reduction -20 -40 -60 -80 -100 -120 0-24 0-48 0-72 Time Interval After Study Drug Administra
Slide 13: Conclusions
Conclusions • HTX-011’s unique formulation significantly reduced pain intensity through the first 72 hours after bunionectomy compared with either bupivacaine HCl or saline placebo – Mean pain scores remained well below the severe pain threshold through the entire 72-hour study period after treatmen