SAN DIEGO, July 21, 2021 /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 the online publication of new
analysis evaluating the efficacy and safety of ZYNRELEF
(bupivacaine and meloxicam) extended-release solution in adults
aged 65 years and older undergoing bunionectomy and hernia repair
from the Phase 3 EPOCH 1 and EPOCH 2 studies. The analysis,
published in the peer-reviewed journal Pain Management,
showed that 58% of bunionectomy and 87% of hernia repair patients
aged 65 years and older receiving ZYNRELEF required no opioids to
manage their postoperative pain through 72 hours following surgery.
Further, throughout the 72-hour period, the mean pain intensity
never rose above the mild range.
ZYNRELEF is an extended-release solution of bupivacaine and
meloxicam that is indicated in adults for soft tissue or
periarticular instillation to produce postsurgical analgesia for up
to 72 hours after bunionectomy, open inguinal herniorrhaphy, and
total knee arthroplasty.
In this post-hoc analysis, those 65 years and older who were
administered ZYNRELEF used fewer opioids in bunionectomy and
herniorrhaphy compared with bupivacaine (7.7 morphine milligram
equivalents (MME) vs 15 MME, and 1.7 MME vs 3.5 MME, respectively).
Importantly, a greater proportion of patients 65 years and older
required no opioids (i.e., opioid-free) through 72 hours (58% vs
25%, and 87% vs 64%, respectively).
ZYNRELEF was well tolerated in patients 65 years and older, with
a safety profile similar to that for bupivacaine. The safety was
also similar to patients aged younger than 65 years and to the
overall populations in the Phase 3 studies. No local anesthetic
systemic toxicity events occurred and serious adverse events were
rare with none considered related to ZYNRELEF.
"Adults ages 65 and over account for approximately half of all
surgeries in the United States
each year and are commonly prescribed opioids to treat pain
following surgery," said Gary M.
Oderda, Pharm.D., MPH, Professor, Director Utah Medicaid
Drug Regimen Review Center & Director, Pharmacotherapy Outcomes
Research Center, and an author of the publication. "In addition, as
people age, medications affect them more strongly and are slower to
leave their systems, so the side effects of opioids can be severe.
This analysis shows ZYNRELEF demonstrated reduction in both pain
and the need for opioids in those 65 years and older, which could
eliminate the risks of taking opioids without compromising patient
care."
ZYNRELEF is the first and only local anesthetic that has been
clinically shown to significantly reduce pain, including severe
pain, better than bupivacaine, the current standard-of-care, for up
to 72 hours and to significantly reduce or eliminate opioid use in
many patients following surgery.
The Pain Management article can be found here.
Important Safety Information for Patients
ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory
drug), a type of medicine which:
- can increase the risk of a heart attack or stroke that can
lead to death. This risk increases with higher doses and longer use
of an NSAID.
- cannot be used during heart bypass surgery.
- can increase the risk of gastrointestinal bleeding, ulcers,
and tears.
ZYNRELEF should also not be used if you are allergic to any
components of ZYNRELEF, aspirin or other NSAIDs (such as ibuprofen
or naproxen), or have had an asthma attack, hives, or other
allergic reaction after taking any of these medicines; or as a
paracervical block, during childbirth.
The most common side effects of ZYNRELEF are constipation,
vomiting, and headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) can
affect the nervous and cardiovascular system; may cause liver or
kidney problems; may reduce the effects of some blood pressure
medicines; should be avoided if you have severe heart failure; may
cause a rare blood disorder, or life-threatening skin or allergic
reactions; may harm your unborn baby if received at 20 weeks of
pregnancy or later; and may cause low red blood cells (anemia).
Please see full Prescribing
Information, including Boxed
Warning.
About ZYNRELEFTM for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic
(DALA) that delivers a fixed-dose combination of the local
anesthetic bupivacaine and a low dose of nonsteroidal
anti-inflammatory drug meloxicam. ZYNRELEF is the first
modified-release local anesthetic to be classified by FDA as an
"extended-release" product because ZYNRELEF is also the first and
only extended-release local anesthetic to demonstrate in Phase 3
studies significantly reduced pain and significantly increased
proportion of patients requiring no opioids through the first
72 hours following surgery compared to bupivacaine solution, the
current standard-of-care local anesthetic for postoperative pain
control. ZYNRELEF was approved by the FDA in May 2021 for use in adults for soft tissue or
periarticular instillation to produce postsurgical analgesia for up
to 72 hours after bunionectomy, open inguinal herniorrhaphy and
total knee arthroplasty. Safety and efficacy have not been
established in highly vascular surgeries, such as intrathoracic,
large multilevel spinal, and head and neck procedures.
In September 2020, the European Commission granted a
marketing authorization for ZYNRELEF for the treatment of somatic
postoperative pain from small- to medium-sized surgical wounds in
adults. As of January 1, 2021,
ZYNRELEF is approved in 31 European countries including the
countries of the European Union and European Economic Area and
the United Kingdom. For more information visit
ZYNRELEF.com
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. Our advanced science,
patented technologies, and innovative approach to drug
discovery and development have allowed us to create and
commercialize a portfolio of products that aim to advance the
standard-of-care for acute care and oncology patients. 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, the timing of the commercial launch of ZYNRELEF
in Europe; the potential market opportunity for ZYNRELEF in
the US and Europe; the extent of
the impact of the ongoing Coronavirus Disease 2019 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 and Media Contact:
David Szekeres
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.