SAN DIEGO, July 1, 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 ZYNRELEF (bupivacaine and
meloxicam) extended-release solution, is now commercially available
at all national wholesalers and the largest specialty distributors
in the United States. 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.
"We are pleased that ZYNRELEF is now available for ordering at
hospitals and ambulatory surgical centers (ASCs) across
the United States, as the first
and only extended-release dual-acting local anesthetic," said Barry
Quart, Pharm.D., Chairman and Chief Executive Officer of Heron.
"ZYNRELEF is the only local anesthetic for postoperative pain
designated by the FDA to be extended-release for up to 72 hours
after surgery, which may help patients and healthcare providers
reduce overreliance on opioids but also mitigate exposure to their
unwanted side effects and the potential for long-term safety risks
like opioid misuse, abuse, or addiction."
Heron's new acute care sales team has extensive operating room,
postoperative pain, and hospital launch experience. Heron's
commercial organization has a proven track record of hospital
success through our launch of CINVANTI® in 2018.
The team has been meeting with key customers and has executed
contracts for ZYNRELEF with the two largest group purchasing
organizations, Vizient and Premier Inc.
ZYNRELEF 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
Important Safety Information for Patients
ZYNRELEF contains an NSAID (nonsteroidal 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 ZYNRELEF™ 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
About CINVANTI (Aprepitant) Injectable Emulsion
CINVANTI, in combination with other antiemetic agents, is
indicated in adults for the prevention of acute and delayed nausea
and vomiting associated with initial and repeat courses of highly
emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
as a single-dose regimen, delayed nausea and vomiting associated
with initial and repeat courses of moderately emetogenic cancer
chemotherapy (MEC) as a single-dose regimen, and nausea and
vomiting associated with initial and repeat courses of MEC as a
3-day regimen. CINVANTI is an IV formulation of aprepitant, an
NK1 receptor antagonist (RA). CINVANTI is the first IV
formulation to directly deliver aprepitant, the active ingredient
in EMEND® capsules. Aprepitant (including its
prodrug, fosaprepitant) is the only single-agent
NK1 RA to significantly reduce nausea and vomiting
in both the acute phase (0–24 hours after chemotherapy) and the
delayed phase (24–120 hours after chemotherapy).
The FDA-approved dosing administration included in the
U.S. prescribing information for CINVANTI is a 30-minute IV
infusion or a 2-minute IV injection.
CINVANTI is under investigation for the treatment of
COVID-19 as a daily 2-minute IV injection when added to the current
standard of care.
Please see full prescribing information
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 U.S. 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.