SAN DIEGO, Sept. 28, 2020 /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 European Commission
has granted a marketing authorization for ZYNRELEF (formerly known
as HTX-011) for the treatment of somatic postoperative pain from
small- to medium-sized surgical wounds in adults. The marketing
authorization follows the European Medicines Agency's (EMA)
positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) in July 2020. Heron
currently expects to make ZYNRELEF available to patients in the
European Union (EU) during 2021.
ZYNRELEF is a non-opioid, dual-acting analgesic, utilizing a
fixed-dose combination of the local anesthetic bupivacaine with a
low dose of the nonsteroidal anti-inflammatory drug meloxicam. For
approximately 72 hours after ZYNRELEF is applied into the surgical
site, ZYNRELEF releases bupivacaine and meloxicam, which are then
absorbed into the surrounding tissues. Meloxicam potentiates the
effect of bupivacaine, resulting in an increase in analgesia.
The European Commission's authorization of ZYNRELEF is based on
the results of Heron's two multi-center, double-blind, active and
placebo-controlled Phase 3 studies of ZYNRELEF. The primary
endpoint and all 4 key secondary endpoints were met in both Phase 3
studies. ZYNRELEF demonstrated significantly reduced pain and
opioid use through 72 hours compared to saline placebo and to
bupivacaine solution, the current standard-of-care local anesthetic
for postoperative pain control. ZYNRELEF also significantly
increased the proportion of patients who required no postoperative
opioids. The most common side effect with ZYNRELEF is
dizziness.
The European Commission's centralized marketing
authorization is valid for the 27 countries that are members of the
EU and the United Kingdom.
Norway, Iceland and Liechtenstein will make corresponding
decisions based on the decision of the European Commission.
"The authorization of ZYNRELEF in the EU is an important
milestone for Heron, as well as for the millions of surgical
patients in the EU for whom safety, pain relief and recovery are of
primary importance," said Barry Quart, Pharm.D., President and
Chief Executive Officer of Heron. "With a novel dual mechanism of
action, and single, needle-free application, ZYNRELEF has been
clinically shown to better manage severe pain than standard-of-care
bupivacaine over 72 hours and we believe that ZYNRELEF adds an
effective therapeutic option for the management of postoperative
pain for eligible patients."
About ZYNRELEF (Approved in the European Union)
ZYNRELEF, a non-opioid analgesic, 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 saline placebo and to bupivacaine solution,
the current standard-of-care local anesthetic for postoperative
pain control. ZYNRELEF is indicated for the treatment of somatic
postoperative pain from small- to medium-sized surgical wounds in
adults. Efficacy and safety have not been established in major
surgeries, including abdominal, vascular and thoracic surgeries.
ZYNRELEF should be administered in a setting where trained personal
and equipment are available to ensure prompt treatment of any toxic
neurological or cardiac effects. ZYNRELEF received authorization
from the European Commission in September
2020.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid analgesic, 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. The U.S. Food and Drug
Administration (FDA) granted Breakthrough Therapy designation to
HTX-011 and the New Drug Application (NDA) received Priority Review
designation. A complete response letter (CRL) was received from the
FDA regarding the NDA for HTX-011 in June
2020 relating to non–clinical information. No clinical
safety or efficacy issues and no chemistry, manufacturing and
controls (CMC) issues were identified. Heron's New Drug Submission
(NDS) for HTX-011 for the management of postoperative pain was
granted Priority Review status and accepted by Health Canada. Heron
is working to respond to a list of questions received from Health
Canada in July 2020.
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: the timing of the NDA
resubmission to the FDA; whether the FDA approves the NDA for
HTX-011; the timing of the commercial launch of HTX-011 in the
U.S.; the timing of the commercial launch of ZYNRELEF in
Europe; the timing of Health
Canada's NDS review process for HTX-011; whether Health
Canada issues a Notice of Compliance for the NDS for HTX-011;
the extent of the impact of the ongoing Coronavirus Disease 2019
(COVID-19) pandemic on our business 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 Contact:
David Szekeres
Chief Legal, Business and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
View original
content:http://www.prnewswire.com/news-releases/heron-therapeutics-receives-european-commission-authorization-for-zynrelef-htx-011-for-the-treatment-of-postoperative-pain-301138692.html
SOURCE Heron Therapeutics, Inc.