- The VAN has the potential to simplify
aseptic preparation, while also significantly reducing ZYNRELEF's
withdrawal time
- The VAN is expected to launch in Q4
2024
SAN
DIEGO, Sept. 25, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a
commercial-stage biotechnology company, today announced that the
U.S. Food and Drug Administration (the "FDA") has approved the
Company's Prior Approval Supplement Application for
ZYNRELEF® (bupivacaine and meloxicam) extended-release
solution VAN.
The VAN will replace the current vented vial spike and has the
potential to simplify aseptic preparation, while also significantly
reducing ZYNRELEF's withdrawal time down to between twenty and
forty-five seconds. The user-friendly "container-like" design of
the VAN may enhance the safe use of ZYNRELEF, increase adoption,
and improve the preparation process.
"With this approval, we are providing healthcare providers with
a new mechanism that directly addresses one of ZYNRELEF's adoption
hurdles and will help reduce preparation time for surgical staff,"
said Bill Forbes, PharmD, Executive
Vice President, Chief Development Officer at Heron. "Reducing
patients' pain during the first three days after surgery is
critical for patient recovery and well-being following often
painful procedures, and we anticipate the VAN will lead to
increased ZYNRELEF adoption, positively impacting patient
recovery."
"The VAN approval, along with ZYNRELEF's January label
expansion, its inclusion in the proposed 2025 Non-Opioid Policy for
Pain Relief ("NOPAIN Act"), and the continued integration of our
partnership with CrossLink Life Sciences, LLC ("CrossLink"), are
all exciting milestones achieved during 2024 contributing to
ZYNRELEF's continued progress," said Craig Collard, Chief
Executive Officer at Heron. "We remain optimistic about the
potential transformative impact the VAN will have, following its
expected launch in Q4 2024, providing healthcare professionals with
an easier to use, versatile, and effective solution for managing
postoperative pain across a wide range of surgical procedures."
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic 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 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 initially 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. In December 2021, the FDA approved an expansion of
ZYNRELEF's indication to include foot and ankle, small-to-medium
open abdominal, and lower extremity total joint arthroplasty
surgical procedures. On January 23,
2024, the FDA approved ZYNRELEF for soft tissue and
orthopedic surgical procedures including foot and ankle, and other
procedures in which direct exposure to articular cartilage is
avoided. Safety and efficacy have not been established in highly
vascular surgeries, such as intrathoracic, large multilevel spinal,
and head and neck procedures.
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 component of ZYNRELEF, similar local
anesthetics, 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.
- as a paracervical block, during childbirth.
The most common side effects of ZYNRELEF are soft tissue
procedures: vomiting and orthopedic procedures: constipation and
headache.
The medicines in ZYNRELEF (a local anesthetic and an NSAID) may
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 adverse effects on cartilage; 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).
Tell your healthcare provider about all your medical conditions
and about all the medicines you take including prescription or
over-the-counter medicines, vitamins, or herbal supplements to
discuss if ZYNRELEF is right for you.
Talk to your healthcare provider for medical advice about side
effects. Report side effects to Heron at 1-844-437-6611 or to FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
The information provided here is not comprehensive. Please see
full Prescribing Information, including Boxed Warning, at
www.ZYNRELEF.com.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology
company focused on improving the lives of patients by developing
and commercializing therapeutic innovations that improve medical
care. 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. Therefore,
you should not place undue reliance on forward-looking statements.
Examples of forward-looking statements include, among others,
statements we make regarding the potential market opportunities for
ZYNRELEF®, APONVIE®, CINVANTI® and
SUSTOL®; revenue, adjusted EBITDA and other financial
guidance provided by the Company; the results of the commercial
launch of APONVIE; the potential additional market opportunity for
the expanded U.S. label for ZYNRELEF; the timing of the
Company's development of the VAN program and receipt of required
regulatory approvals; the realization of anticipated benefits from
receipt of required regulatory approvals and/or launch of the VAN;
the Company's ability to establish and maintain successful
commercial arrangements like our co-promotion agreement
with CrossLink; the realization of anticipated benefits from
our co-promotion agreement with CrossLink; the outcome of the
Company's pending abbreviated new drug application litigation;
whether the Company is required to write-off any additional
inventory in the future; the expected future balances of Heron's
cash, cash equivalents and short-term investments; the expected
duration over which Heron's cash, cash equivalents and short-term
investments balances will fund its operations and the risk that
future equity financings may be needed; any inability or delay in
achieving profitability. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements are set forth in our most recent Annual Report on Form
10-K and any subsequent Quarterly Reports on Form 10-Q, and in our
other reports filed with the Securities and Exchange
Commission, including under the caption "Risk Factors."
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:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.
