SAN DIEGO, July 24, 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 Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) adopted a positive opinion, recommending the granting of a
marketing authorisation for ZYNRELEF (formerly known as
HTX-011), intended for the treatment of postoperative
pain.
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,
where meloxicam enhanced the efficacy of bupivacaine. ZYNRELEF uses
Heron's proprietary Biochronomer® polymer delivery
system to slowly release these drugs over approximately 72
hours.
The CHMP's positive opinion is based on the results of Heron's
two 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 bupivacaine solution, the current
standard-of-care anesthetic for postoperative pain control.
ZYNRELEF significantly reduced pain intensity through 72 hours
post–surgery, significantly reduced the use of opioid medications
following surgery and significantly increased the proportion of
patients who required no postoperative opioid medications. In both
studies, ZYNRELEF was generally well tolerated, with a safety
profile comparable to placebo and bupivacaine solution.
The CHMP's positive opinion will now be reviewed by the European
Commission (EC), with a final decision on the Marketing
Authorisation Application expected in the coming months. An EC
marketing authorisation through the centralized procedure is valid
in all 27 European Union (EU) member countries as well as the
European Economic Area countries. The CHMP recommended that
ZYNRELEF be indicated for treatment of somatic postoperative pain
from small- to medium-sized surgical wounds in adults.
"Managing postoperative pain remains a major challenge for many
physicians, given that up to 80% of patients across Europe report moderate to severe pain for
several days after surgery. Postoperative pain causes avoidable
suffering, resulting in longer hospital stays and higher healthcare
costs," said Richard Langford M.D.,
FRCA, FFPMRCA, Honorary Consultant, Pain and Anaesthesia
Research Centre, St. Bartholomew's Hospital, Barts Health NHS
Trust, London, United Kingdom.
"The indication recommended by the CHMP will allow surgeons to use
the product for a wide range of surgeries, enabling a broad range
of patients to benefit from the prolonged action of this important
product."
"Obtaining a positive opinion from the CHMP for ZYNRELEF is a
major regulatory milestone and confirms the superiority of ZYNRELEF
over bupivacaine solution, the current standard of care," said
Barry Quart, Pharm.D., President and Chief Executive Officer of
Heron. "We believe that the CHMP's positive opinion of ZYNRELEF is
an important step forward to help improve the lives of patients
across the EU by significantly reducing the proportion of patients
who experience severe pain after surgery."
About ZYNRELEF (HTX-011) for Postoperative Pain
ZYNRELEF, 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. 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
2018 and received Priority Review designation in
December 2018. A Complete Response
Letter (CRL) was received from the FDA regarding the NDA for
HTX-011 on June 26, 2020 relating to
non–clinical information. No clinical safety or efficacy issues and
no chemistry, manufacturing and controls (CMC) issues were
identified. The European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
for ZYNRELEF in July 2020. Heron's New Drug Submission (NDS)
for HTX-011 for the management of postoperative pain was granted
Priority Review status by Health Canada in October 2019 and accepted by Health Canada in
November 2019. 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: whether the U.S. Food
and Drug Administration (FDA) approves the New Drug
Application (NDA) for HTX-011; the timing of the commercial launch
of HTX-011 in the U.S.; whether the European Commission (EC)
authorizes the Marketing Authorisation Application for ZYNRELEF;
the timing of the commercial launch of ZYNRELEF in
Europe; the timing of Health
Canada's New Drug Submission (NDS) review process for HTX-011;
whether Health Canada issues a Notice of Compliance for the
NDS 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 Contact:
David Szekeres
Chief Legal, Business and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.