Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Technical Presentation (2021)
6 slides from Heron Therapeutics's technical presentation, 2021
Slide 1: No Evidence of Bone-Healing Impairment or NSAID-Related Toxicity With ZYNRELEF (HTX-011)
No Evidence of Bone-Healing Impairment or NSAID-Related Toxicity With (ZYNRELEF) HTX-011 Peter Sculco, MD1, Richard Pollak, DPM, MS2, Ross Rudolph, MD, FACS3, Christopher K. Bromley, DPM4, Susan Y. Smith, MSc5, Clynn Wilker, DVM, PhD6 1Hospital for Special Surgery, New York, NY, 2Endeavor Clinical T
Slide 2: Purpose
Purpose There are questions about the risk of impaired bone healing from NSAID administration after arthroplasty or osteotomy ZYNRELEF is a dual-acting local anesthetic comprising bupivacaine and low- dose meloxicam in an extended-release polymer The low dose of meloxicam reduces inflammation
Slide 3: Materials and Methods
Materials and Methods Studies and Assessments Study Description Treatment Regimens Safety Assessments Preclinical Studies • ZYNRELEF 14.6 mg /0.44 mg (n=8) • CT post-surgery days 1, 6, 13, 20, 34 (1 study) Rat surgical bone defect model • Saline placebo (n=8) • Radiography post-surgery days 1, 14, 2
Slide 4: Results: Normal Bone Healing
Results Clinical Studies Normal Bone Healing Normal healing HTX-011 Bupivacaine HCl Placebo Phase 2 Study N=168 N=24 N=98 N (%) 168 (100) 24 (100) 98 (100) Preclinical Studies EPOCH-1 Study Day 28 Day 42 Day 28 Day 42 Day 28 Day 42 N (%) N=144 N=153 N=148 N=149 N=99 N=100 143 (99) 152 (99) 147 (99)
Slide 5: Results: Incidence of Potential NSAID-related AEs Similar to Controls
Results Incidence of Potential NSAID-related AEs Similar to Saline and Bupivacaine Controls EPOCH-1 (Phase 3 Pivotal Trial) EPOCH-1 Follow-On Saline Placebo Bupivacaine HCl ZYNRELEF ZYNRELEF (n=101) 50 mg 60 mg/1.8 mg <60 mg/1.8 mg + MMA n, (%) (n=154) (n=157) (n=31) Patients reporting >1 NSAID-rela
Slide 6: Conclusions
Conclusions ZYNRELEF did not impair bone healing in a surgical rat bone defect model or in studies of patients undergoing bunionectomy with osteotomy ZYNRELEF did not increase the incidence of NSAID-related AEs compared to saline or bupivacaine and was well tolerated when used as the foundation