SAN DIEGO, May 21, 2019 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company focused on improving the lives of patients by developing
best-in-class treatments to address some of the most important
unmet patient needs, today announced that the results from the
pivotal Phase 3 EPOCH 1 bunionectomy study of the investigational
agent HTX-011 have been published online by the Regional
Anesthesia & Pain Medicine (RAPM) journal. The article,
entitled "HTX-011 reduced pain intensity and opioid consumption
versus bupivacaine HCl in bunionectomy: phase III results from the
randomized EPOCH 1 study," also will be published in the
July 2019 print issue of RAPM.
HTX-011 achieved all primary and key secondary endpoints in the
EPOCH 1 study, demonstrating statistically significant reductions
in both pain intensity and the use of opioid rescue medications
following surgery and an increase in the proportion of patients who
were opioid-free.
HTX-011 is a dual-acting, fixed-dose combination of the local
anesthetic bupivacaine with a low dose of the nonsteroidal
anti-inflammatory drug meloxicam in a 33:1 ratio. It is the
first and only extended-release local anesthetic to demonstrate in
Phase 3 studies significantly reduced pain and opioid use through
72 hours compared to bupivacaine solution, the current
standard-of-care local anesthetic for postoperative pain
control.
In the EPOCH 1 study, all primary and key secondary endpoints
were achieved. HTX-011 provided superior and sustained pain
reduction compared to placebo and bupivacaine solution through the
critical 72-hour postoperative window, when pain is often most
severe. Significant reductions in pain occurred both early (in the
first 8 through 24 hours) and were sustained from 24 through 72
hours. In addition to reductions in average pain intensity scores,
HTX-011 significantly reduced the proportion of patients
experiencing severe pain through 72 hours compared to placebo and
bupivacaine solution. Significant reductions in pain were
consistent with the significant decrease in total opioid
consumption and the significant increase in opioid-free patients
receiving HTX-011, both through 72 hours and as compared to placebo
and bupivacaine solution. Most patients that required no opioids in
the first 72 hours after surgery (82%) continued to be opioid-free
through 28 days. HTX-011 was well tolerated, with a safety profile
comparable to placebo and bupivacaine solution.
"This publication demonstrates that HTX-011 can significantly
reduce postoperative pain, including severe pain, for 72 hours
post-surgery and reduce the need for opioids compared to
bupivacaine solution," said Eugene
Viscusi, MD, Professor of Anesthesiology and Chief of Pain
Medicine in the Department of Anesthesiology at the Sidney Kimmel
Medical College of Thomas Jefferson
University in Philadelphia,
Pennsylvania. "Surgery can contribute to the opioid problem,
as it is often a patient's initial introduction to opioids, and it
also can be the trigger for misuse and abuse due to unused pills
from discharge prescriptions. Each year, an estimated 2.6 million
Americans may become persistent opioid users following initial
opioid exposure after surgery. The results from EPOCH 1 suggest
that HTX-011 can be used to control pain effectively after surgery,
thereby reducing the reliance on opioids and preventing the flow of
unused opioid pills into our homes and communities."
The RAPM article can be found here.
About the EPOCH 1 Study
EPOCH 1 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/1.8 mg
bupivacaine/meloxicam compared to placebo and the standard dose of
bupivacaine solution (50 mg) for postoperative pain control
following bunionectomy surgery in 412 patients. All primary and key
secondary endpoints were achieved:
- There was a 27% reduction in pain intensity as measured by the
Area Under the Curve (AUC) 0-72 when comparing HTX-011 to placebo
(p<0.0001).
- There was an 18% reduction in pain intensity as measured by AUC
0-72 when comparing HTX-011 to the current standard-of-care,
bupivacaine solution (p=0.0002).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed
37% less opioids than patients receiving placebo (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 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 solution (29%
reduction; p<0.0001).
- Among the HTX-011-treated patients who were opioid-free through
72 hours post-surgery, more than 90% remained opioid free through
day 10 and 82% remained opioid free through day 28.
- HTX-011 was well tolerated, with a safety profile comparable to
placebo and bupivacaine solution.
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 management 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 solution in five
diverse surgical models: hernia repair, abdominoplasty,
bunionectomy, total knee arthroplasty and breast augmentation.
HTX-011 was granted Fast Track designation from the U.S. Food
and Drug Administration (FDA) in the fourth quarter of 2017 and
Breakthrough Therapy designation in the second quarter of 2018.
Heron submitted a New Drug Application (NDA) to
the FDA for HTX-011 in October of 2018 and received
Priority Review designation in December of 2018. A Complete
Response Letter was received from the FDA regarding the NDA for
HTX-011 on April 30, 2019 relating to
chemistry, manufacturing and controls and non-clinical information.
No issues related to clinical efficacy or safety were noted. A
Marketing Authorisation Application for HTX-011 was validated
by the European Medicines Agency in March 2019 for review under the Centralised
Procedure.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage
biotechnology company focused on improving the lives of patients by
developing best-in-class treatments to address some of the most
important unmet patient needs. Heron is developing novel,
patient-focused solutions that apply its innovative science and
technologies to already-approved pharmacological agents for
patients suffering from pain or cancer. For more information,
visit www.herontx.com.
Forward-looking Statements
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: whether the FDA approves
the NDA for HTX-011; the timing of the commercial launch of
HTX-011; the timing of the CHMP's review process for HTX-011;
whether the European Commission authorizes the MAA for HTX-011; and
other risks and uncertainties identified in the Company's filings
with the U.S. Securities and Exchange Commission.
Forward-looking statements reflect our analysis only on their
stated date, and Heron takes no obligation to update or revise
these statements except as may be required by law.
Investor Relations and Media Contact:
David Szekeres
Senior VP, General Counsel, Business Development and Corporate
Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.