SAN DIEGO, July 28, 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 results from the HOPE
Hernia-1 study of ZYNRELEF (bupivacaine and meloxicam) in hernia
repair surgery have been published online by Pain and
Therapy in an article entitled, "Opioid-Free Recovery After
Hernia Repair With HTX-011 as the Foundation of a Non-Opioid,
Multimodal Analgesia Regimen in a Real-World Setting." In this
study, ZYNRELEF, used with scheduled over-the-counter oral
analgesics (acetaminophen and ibuprofen) and a personalized opioid
prescription algorithm in a real-world environment, enabled more
than 90% of patients to be discharged without an opioid
prescription, with no callbacks for pain management and 95% of
patients to recover opioid-free.
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.
"Despite efforts to combat the nation's growing opioid crisis,
recent evidence suggests that clinical practice is lagging and
opioids are still overprescribed after inguinal herniorrhaphy,"
said Jay Redan, M.D., FACS, Chief of
Surgery at Advent Health-Celebration in Celebration, Florida and an author of the
publication. "The findings from this study demonstrate the ability
of ZYNRELEF to serve as the foundation of non-opioid multimodal
analgesia. These data also show ZYNRELEF, in conjunction with an
algorithm that distinguishes between patients who need or do not
need a discharge opioid prescription, could further increase the
proportion of opioid-free patients, decrease the amount of opioids
required per patient, and decrease the total number of opioid pills
prescribed at discharge after surgery."
The study, HOPE Hernia-1, is part of the HOPE project, which is
designed to provide surgeons with practical real-world solutions to
effectively manage postoperative pain and eliminate the need for
opioid prescriptions using ZYNRELEF as the foundation of a
scheduled non-opioid multimodal analgesic regimen.
The Pain and Therapy 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,
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
About Helping Opioid Prescription Elimination (HOPE)
The study, Helping Opioid Prescription Elimination Hernia-1
(HOPE Hernia-1), is part of the HOPE project, which is designed to
provide surgeons with practical real-world solutions to effectively
manage postoperative pain and eliminate the need for opioid
prescriptions using a ZYNRELEF-based non-opioid multimodal
analgesia (MMA) regimen. All patients received oral ibuprofen 400
mg and acetaminophen 1 g approximately 2 hours before surgery and
at the end of surgery all patients received intraoperative ZYNRELEF
(300 mg bupivacaine/9 mg meloxicam) administered via needle-free
application into the surgical site after final irrigation and
suction of fascial layers and prior to suturing. The study
randomized patients into two cohorts receiving non-opioid
multimodal analgesia regimens – concurrent versus alternating
ibuprofen and acetaminophen – following herniorrhaphy. A
personalized algorithm determined eligibility for an opioid
prescription at discharge: Numeric rating scale (NRS) pain score ≥6
and/or receipt of a postoperative opioid prior to discharge. Key
results of the study include the following:
- The majority of patients (85/93; 91.4%) did not receive an
opioid prescription at discharge or at any time through 2 weeks
after surgery, and the results were similar between cohorts
(alternating MMA, 89.1%; concurrent MMA, 93.6%).
- Overall, 94.6% of patients were opioid-free through the 2-week
- The mean discharge time following surgery was 2.6 hours in the
alternating MMA cohort and 2.2 hours in the concurrent MMA
- Of the 98% of patients who completed the TSQM-9, most patients
were "very" or "extremely" satisfied with their MMA regimen.
ZYNRELEF plus acetaminophen and ibuprofen was well tolerated;
safety results were similar between concurrent and alternating MMA
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 U.S. Food and Drug
Administration (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 (EC) 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.
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.
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:
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
SOURCE Heron Therapeutics, Inc.