Heron Therapeutics Reports Positive Top-Line Results from Phase 2 Studies of HTX-011 for Management of Post-Operative Pain
-Statistically and clinically significant reductions in pain intensity through 96 hours after bunion surgery and through 48 hours after hernia surgery
-Increase in time to first opioid rescue and decrease in overall opioid use in both studies
-HTX-011 statistically superior to standard-of-care bupivacaine solution on both pain intensity and opioid use
-HTX-011 shown effective when administered by infiltration or by
-Instillation, an easier, less invasive and potentially safer route of administration into the wound, was equally as effective as injection
-Conference call and webcast at
Study 208 – Bunionectomy
Study 208 was a randomized, placebo- and active-controlled, double-blind
Phase 2 clinical study in patients undergoing bunionectomy. This study
evaluated the efficacy and safety of two formulations of HTX-011 at 200
mg compared to the standard dose of bupivacaine solution and placebo.
Bupivacaine solution is the standard-of-care agent for the management of
post-operative pain. In addition, HTX-011 was evaluated when
The primary endpoint was the difference as compared to placebo in pain
intensity as measured by the Summed Pain Intensity (SPI) score in the
first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included
comparison to bupivacaine solution, the time to first use of opioid
rescue medication, total opioid consumption and difference in pain
intensity compared to placebo or bupivacaine solution when administered
- There was a 66% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by infiltration to placebo (p<0.0001). There was a 64% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by infiltration to bupivacaine solution (p<0.0001).
- There was a 69% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to placebo (p<0.0001). There was a 71% reduction in pain as measured by SPI 0-24 when comparing HTX-011 administered by nerve block to bupivacaine solution (p<0.0001).
- Significant reductions in pain were maintained through 96 hours post-surgery (SPI 0-96) for all groups: HTX-011 by infiltration versus placebo (p=0.005), HTX-011 by infiltration versus bupivacaine solution (p=0.019), HTX-011 by nerve block versus placebo (p=0.004), and HTX-011 by nerve block versus bupivacaine solution (p=0.007).
- Mean time to first opioid rescue medication was 716% longer than for placebo (p<0.0001) and 167% longer than for bupivacaine solution (p<0.036).
- Over the first 24 hours post-surgery, patients receiving HTX-011 consumed 74% less opioids than placebo patients (p<0.0001) and 67% less than bupivacaine solution patients. Over the first 96 hours post-surgery, patients receiving HTX-011 consumed 53% less opioids than placebo patients (p=0.003) and 50% less than bupivacaine solution patients (p=0.008).
Study 202 – Inguinal Hernia Repair
Study 202 was a randomized, placebo-controlled, double-blind Phase 2 clinical study in patients undergoing inguinal hernia repair. The study evaluated the efficacy and safety of two formulations of HTX-011 at two doses (200 mg and 400 mg), compared to placebo.
In addition, two routes of administration into the wound (injection and instillation) were evaluated. Instillation into the incision site is an easier and potentially safer route of administration as it avoids multiple injections around the wound (as many as 10 or more in large operations) that carry the risk of venous puncture.
The primary endpoint was the difference as compared to placebo in pain intensity as measured by SPI 0-24. Key secondary endpoints included the time to first use of opioid rescue medication and total opioid consumption. The major findings for the 400 mg dose of our Phase 3 formulation of HTX-011 as compared to placebo are as follows:
- There was a 29% reduction in pain as measured by SPI 0-24 (p=0.008).
- HTX-011 by instillation (28.4% reduction in SPI 0-24) was equally as effective as HTX-011 by injection (29.2% reduction in SPI 0-24).
- The pain reduction was long-lasting, with a statistically significant, 25% reduction through 48 hours (SPI 0-48; p=0.038).
- Mean time to first opioid rescue medication was 110% longer (13.3 hours versus 27.9 hours).
- Mean total opioid consumption was 36% less through 96 hours post-surgery.
- The number of patients that did not take any opioid rescue medication at all through 96 hours post-surgery was approximately double (21% versus 11%).
HTX-011 has been generally well tolerated in the ongoing Phase 2 program, which has involved more than 250 administrations of HTX-011. The most frequent treatment-related adverse events reported have been nausea and vomiting, which occurred at similar rates in active and control patients.
“With today’s results in hand, we could not be more excited about the
potential of HTX-011 to represent a best-in-class therapeutic for
post-operative pain,” commented Barry D. Quart, PharmD, Chief Executive
Conference Call and Webcast
Heron Therapeutics will host a conference call and webcast on Monday,
August 1, 2016 at 8:30 a.m. ET (
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 is the subject of a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain.
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release, and
involve substantial risks and uncertainties that could cause our
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or implied by
the forward-looking statements. These risks and uncertainties include,
but are not limited to, those associated with: whether the Phase 2 study
results are indicative of the results in future studies related to
HTX-011, the sufficiency of the Phase 2 data to allow the commencement
of Phase 3 registration studies for HTX-011, the potential market
opportunity for HTX-011, and other risks and uncertainties identified in
the Company's filings with the
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations