SAN DIEGO, May 29, 2024 /PRNewswire/ -- Heron Therapeutics,
Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage
biotechnology company, today announced the Prior Approval
Supplement ("PAS") submission to the U.S. Food and Drug
Administration ("FDA") for ZYNRELEF® (bupivacaine and
meloxicam) extended-release solution Vial Access Needle
("VAN").
Heron expects to receive the assigned action date for completion
of the FDA's review of this PAS within the next several weeks and
anticipates an action date on this PAS to be between four (4) and
six (6) months.
The ZYNRELEF kit contains a ready-to-use vial and all necessary
components for needle-free application to the patient. The current
kit contains a vented vial spike ("VVS") which can take up to three
(3) minutes to complete product withdrawal, requiring coordination
between both sterile and nonsterile personnel. If approved, the
introduction of the VAN will replace the VVS and has the potential
to simplify aseptic preparation, while also significantly reducing
ZYNRELEF's withdrawal time down to twenty (20) – forty-five (45)
seconds. The user-friendly "container-like" design of the VAN may
enhance the safe use of ZYNRELEF, increase adoption, and improve
the preparation process.
"This VAN submission for ZYNRELEF directly addresses feedback
Heron has received from healthcare providers around the need to
improve the preparation of ZYNRELEF for use. We are excited that
this has the potential to simplify preparation and introduce a more
streamlined process for our clinicians, allowing for more patients
to experience significant pain relief following surgery," said Dr.
Bill Forbes, Executive Vice
President, Chief Development Officer at Heron.
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, the current
standard-of-care. ZYNRELEF demonstrated superiority compared to
bupivacaine with lower pain scores, fewer patients experiencing
severe pain, and lower opioid consumption. ZYNRELEF was initially
approved by the FDA in May 2021,
received approval of the first supplemental New Drug Application
("sNDA") for an expanded label in December
2021, followed by the second sNDA for an expanded label in
January 2024.
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.
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 U.S. Food and Drug Administration (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.
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; our ability to establish and
maintain successful commercial arrangements like our co-promotion
agreement CrossLink Life Sciences; the outcome of the Company's
pending ANDA 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.