SAN DIEGO, Aug. 20, 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 EPOCH 2,
a Phase 3 study of the investigational agent HTX-011 in open
inguinal hernia repair surgery with mesh, have been published in
the journal, Hernia, in an article entitled "HTX-011 reduced
pain intensity and opioid consumption versus bupivacaine HCl in
herniorrhaphy: results from the phase 3 EPOCH 2 study." HTX-011
achieved all primary and key secondary endpoints in EPOCH 2,
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. 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. Heron has completed two
pivotal Phase 3 studies of HTX-011: EPOCH 1 in bunionectomy, which
is a study of a bony tissue surgical model, and EPOCH 2 in hernia
repair, which is a study of a soft tissue surgical model.
In EPOCH 2, 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. HTX-011 was well tolerated, with a safety profile
comparable to placebo and bupivacaine solution.
"Despite the many risks of opioid use, most patients
undergoing hernia repair surgery are prescribed opioids after
surgery," said Sonia Ramamoorthy, M.D., Chief of Colorectal
Surgery at UC San Diego Health. "These data suggest HTX-011 can
significantly reduce postoperative pain, including severe pain, and
help patients reduce and even avoid the need for opioids. For the
approximately 800,000 inguinal hernia repairs done in the United States each year, exposing fewer
patients to opioids and discharging the majority of them without
opioids could have a positive impact on the country's high rate of
opioid dependency."
The Hernia article can be found here.
About EPOCH 2
EPOCH 2 was a randomized, placebo- and active-controlled,
double-blind, pivotal Phase 3 clinical study evaluating the
efficacy and safety of locally administered HTX-011 at 300 mg/9 mg
bupivacaine/meloxicam compared to placebo and the standard dose of
bupivacaine solution (75 mg) for postoperative pain control
following hernia repair surgery in 418 patients. All primary and
key secondary endpoints were achieved:
- There was a 23% reduction in pain intensity as measured by the
Area Under the Curve (AUC) 0–72 when comparing HTX-011 to placebo
(p<0.001).
- There was a 21% reduction in pain intensity as measured by AUC
0–72 when comparing HTX-011 to the current standard-of-care,
bupivacaine solution (p<0.001).
- Over 72 hours post-surgery, patients receiving HTX-011 consumed
38% less opioids than patients receiving placebo (p<0.001) and
25% less opioids than patients receiving bupivacaine solution
(p=0.024).
- 51% of patients receiving HTX-011 required no opioid medication
for 72 hours post-surgery compared to only 22% receiving placebo
(p<0.001) and 40% receiving bupivacaine solution (p=0.049).
These results parallel the significantly reduced incidence of
severe pain in patients receiving HTX-011 compared to both placebo
(40% reduction; p<0.001) and bupivacaine solution (19%
reduction; p=0.037).
- Among the HTX-011-treated patients who were opioid-free through
72 hours post-surgery, more than 84% 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 (MAA) for HTX-011 was
validated by the European Medicines Agency (EMA) 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 EMA Committtee for
Medicinal Products for Human Use (CHMP) 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.