Heron Announces Positive Topline Results From Pivotal Phase 3 Clinical Trials of HTX-011 in Bunionectomy and Hernia Repair
- HTX-011 Achieved All Primary and Key Secondary Endpoints -
- HTX-011 Produced Statistically Significant Reductions in Both Pain Intensity and Need for Opioids through 72 hours Post-Surgery Compared to Placebo and Bupivacaine Solution, the Standard-of-Care -
- Significantly More Patients Receiving HTX-011 Were Opioid-Free through 72 hours after Surgery and Significantly Fewer HTX-011 Patients Experienced Severe Pain at Any Time -
- NDA Filing Targeted for 2H 2018 -
- Conference Call and Webcast Today at
HTX-011 is the first and only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control, through 72 hours.
The primary and key secondary endpoints for both Phase 3 studies were identical.
- The primary endpoint was pain intensity as measured by the Area Under the Curve (AUC) score from 0 to 72 hours post-surgery (AUC 0-72) compared to placebo.
Key secondary endpoints in order of evaluation were:
- comparison of AUC 0-72 of pain intensity to bupivacaine solution;
- the total amount of opioid rescue medication consumption compared to placebo through 72 hours after surgery;
- the proportion of patients who received no opioid rescue medication after surgery compared to bupivacaine solution; and
- the total opioid consumption through 72 hours after surgery compared to bupivacaine.
Bunionectomy (Study 301/EPOCH1) Results
EPOCH1 was a randomized, placebo- and active-controlled, double-blind, Phase 3 clinical study evaluating the efficacy and safety of locally administered HTX-011 at 60 mg compared to the standard dose of bupivacaine solution (50 mg) and placebo for post-operative pain control following bunionectomy surgery in 412 subjects. All primary and key secondary endpoints were achieved:
- There was a 27% reduction in pain intensity as measured by AUC 0-72 when comparing HTX-011 to placebo (p<0.0001).
- There was an 18% reduction in pain as measured by AUC 0-72 when comparing HTX-011 to bupivacaine solution (p=0.0002).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed 37% less opioids than placebo patients (p<0.0001) and 25% less opioids than patients receiving bupivacaine solution (p=0.0022).
- 29% of patients receiving HTX-011 required no opioid medication for 72 hours post-surgery compared to only 2% receiving placebo (p<0.0001) and 11% receiving the standard-of-care, bupivacaine solution (p=0.0001). These results parallel the significantly reduced incidence of severe pain in patients receiving HTX-011 compared to both placebo (36% reduction; p<0.0001) and bupivacaine (29% reduction; p<0.0001).
Hernia Repair (Study 302/EPOCH2) Results
EPOCH2 was a randomized, placebo- and active-controlled, double-blind, Phase 3 clinical study evaluating the efficacy and safety of locally administered HTX-011 at 300 mg compared to the standard dose of bupivacaine solution (75 mg) and placebo for post-operative pain control following hernia repair surgery in 418 subjects. All primary and key secondary endpoints were achieved:
- There was a 23% reduction in pain intensity as measured by AUC 0-72 when comparing HTX-011 to placebo (p=0.0004).
- There was a 21% reduction in pain as measured by AUC 0-72 when comparing HTX-011 to bupivacaine solution (p<0.0001).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed 38% less opioids than placebo patients (p=0.0001) and 25% less opioids than patients receiving bupivacaine solution (p=0.0240).
- 51% of patients receiving HTX-011 required no opioid medication for 72 hours post-surgery compared to only 22% receiving placebo (p<0.0001) and 40% receiving the standard-of-care, bupivacaine solution (p=0.0486). These results parallel the significantly reduced incidence of severe pain in patients receiving HTX-011 compared to both placebo (40% reduction; p<0.0001) and bupivacaine (19% reduction; p=0.0372).
HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution. There were no drug-related serious adverse events or discontinuations due to drug-related adverse events in HTX-011-treated patients, and there were fewer opioid-related adverse events in HTX-011-treated patients.
HTX-011 is the first and only long-acting anesthetic designed to address both postoperative pain and inflammation in a single administration at the surgical site. The unique synergy of bupivacaine and meloxicam in HTX-011 has consistently been shown to reduce pain over 72 hours significantly better than bupivacaine alone in multiple diverse surgical models. HTX-011 is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing, which makes HTX-011’s route of administration faster, easier and potentially safer compared to numerous injections required with current local anesthetics.
“Acute use of opioid pain medications for postoperative pain control is
directly linked to over 2 million new persistent opioid users every year
and up to 440,000 new cases of Opioid Use Disorder annually, making
postoperative opioid use an important contributor to the opioid epidemic
“My family has endured unspeakable tragedy, losing our son, Tyler, to a
heroin overdose that could have been prevented if he was not first
exposed to opioids following a routine elbow surgery. Physicians,
patients and families need new, more effective pain management options
to address postsurgical pain so that we can lessen the number of people
that are exposed to harmful opioids, stopping addiction before it
“With today’s results, HTX-011 is the only locally administered
anesthetic to demonstrate superior pain relief and a reduction in opioid
use as compared to not only placebo, but also the current
standard-of-care, bupivacaine solution, in Phase 3 studies,” said Barry
D. Quart, Pharm.D., Chief Executive Officer of
Conference Call and Webcast
About HTX-011 for Postoperative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery
technology, is an investigational, long-acting, extended-release
formulation of the local anesthetic bupivacaine in a fixed-dose
combination with the anti-inflammatory meloxicam for the prevention of
postoperative pain. By delivering sustained levels of both a potent
anesthetic and a local anti-inflammatory agent directly to the site of
tissue injury, HTX-011 was designed to deliver superior pain relief
while reducing the need for systemically administered pain medications
such as opioids, which carry the risk of harmful side effects, abuse and
addiction. HTX-011 has been shown to reduce pain significantly better
than placebo or bupivacaine alone in three diverse surgical models:
bunionectomy, hernia repair and abdominoplasty. HTX-011 is being
investigated in ongoing Phase 2 studies in nerve block (breast
augmentation) and total knee arthroplasty. The Phase 3 program for
HTX-011 is now complete and Heron today reported positive topline data
from its pivotal bunionectomy and hernia repair studies. HTX-011 was
granted Fast Track Designation from the
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 are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with: the timing of the HTX-011 NDA filing and review
process, and other risks and uncertainties identified in the Company's
filings with the
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