SAN DIEGO, May 13, 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 that the U.S. Food and Drug
Administration (FDA) has approved ZYNRELEF (bupivacaine and
meloxicam) extended-release solution 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. ZYNRELEF, the first
and only extended-release dual-acting local anesthetic (DALA),
delivers a fixed-dose combination of the local anesthetic
bupivacaine and a low dose of the nonsteroidal anti-inflammatory
drug (NSAID) meloxicam. The synergy between bupivacaine and
meloxicam in ZYNRELEF has resulted in patients experiencing
significantly less pain, including severe pain, and significantly
more patients requiring no opioids (opioid-free) after surgery as
compared to bupivacaine solution, the current
standard-of-care.
"The approval of ZYNRELEF marks an exciting milestone for
patients, healthcare providers and pain management. Not just
because it can reduce postoperative pain for up to 72 hours, but
because for many patients it can eliminate the need for opioids
after surgery," said Barry Quart, Pharm.D., Chairman and Chief
Executive Officer of Heron. "We are in a strong position to launch
ZYNRELEF, given our highly successful hospital launch of CINVANTI
and our pricing and unprecedented value proposition, which will
ensure broad access for patients and healthcare providers. Our
existing commercial team will immediately begin working with
current accounts to gain formulary access, with full commercial
availability expected by July
2021."
ZYNRELEF is the first and only therapy for postoperative pain
management to be rigorously tested in Phase 3 studies and
demonstrate superiority to bupivacaine solution. ZYNRELEF
demonstrated superior, sustained postoperative pain relief for up
to 72 hours and decreased the need for opioids, with more patients
opioid-free compared to bupivacaine solution. Clinical studies
included over 1,000 patients, with the most common adverse
reactions following ZYNRELEF administration being constipation,
vomiting, and headache.
"The first three days after surgery are when patients experience
the most severe postsurgical pain and are most likely to receive
opioids to manage that pain. With the impressive reduction in pain
and opioid use demonstrated by ZYNRELEF, we now have an important
new option to help many patients achieve an opioid-free recovery,"
said Roy G. Soto, M.D.,
anesthesiologist at Beaumont Health System. "The dramatic increase
in opioid-related deaths last year highlights the significant need
for safe, effective and non-addictive options to manage pain that
decrease opioid exposure and reduce the need for opioid
prescriptions after surgery."
"Approximately 50 million Americans undergo surgery annually,
and up to 67 percent of those patients receive opioids," said
Alan Rechter, M.D., Orthopaedic
Surgeon at Orthopaedic Associates LLP. "Inadequate postoperative
pain management has been associated with poor patient outcomes,
causing a substantial burden on public health and contributing to
recovery delays. Through today's approval of ZYNRELEF, we now have
a new therapy to offer patients, with the potential to meaningfully
impact the postoperative pain management landscape and reduce, and
even eliminate, unnecessary exposure to opioids in many
patients."
Conference Call and Webcast
Heron will host a conference call and webcast on May 13, 2021 at 8:30 am
ET. The conference call can be accessed by dialing
877-311-5906 for domestic callers and 281-241-6150 for
international callers. Please provide the operator with the
passcode 3922347 to join the conference call. The conference
call will also be available via webcast under the Investor
Relations section of Heron's website at www.herontx.com. An archive
of the teleconference and webcast will also be made available on
Heron's website for 60 days following the call.
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 U.S. Food and Drug
Administration (FDA) on May 12, 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.
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 the U.S.; 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.