– Expanded indication for ZYNRELEF now
covers approximately 13 million procedures annually –
SAN
DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company, today announced that the U.S. Food and Drug Administration
(the "FDA") has approved its supplemental New Drug Application
("NDA") for ZYNRELEF® (bupivacaine and meloxicam)
extended-release solution to expand the indication for soft tissue
and orthopedic surgical procedures including foot and ankle, and
other procedures in which direct exposure to articular cartilage is
avoided. ZYNRELEF was previously approved for foot and ankle,
small-to-medium open abdominal, and lower extremity total joint
arthroplasty surgical procedures in adults.
This expanded indication for ZYNRELEF will now cover an
estimated 13 million procedures annually, an estimated increase of
86% over prior indicated procedures. To obtain this labeling
expansion, Heron successfully conducted studies for cesarean
section, spinal surgery, augmentation mammoplasty, and total
shoulder arthroplasty. No unique safety issues were identified from
the new clinical trials, and the bupivacaine and meloxicam blood
concentrations were consistent with previous experience following
ZYNRELEF administration.
"The expanded indication is poised to have a transformative
impact on patient care, providing healthcare professionals with a
versatile and effective solution for managing postoperative pain
across an even wider range of surgical procedures. The new label
expansion and recent partnership with CrossLink, combined with the
potential approval of the Vial Access Needle ("VAN") later this
year, are expected to have a significant positive impact for
ZYNRELEF and the Company," said Craig
Collard, Chief Executive Officer of Heron.
"We're excited for the opportunity to give even more healthcare
providers and patients a new, safe and effective option for
achieving long-lasting non-opioid pain control after painful
surgical procedures," said Bill
Forbes, Executive Vice President, Chief Development Officer
at Heron. "This new approval further reinforces our commitment to
providing meaningful solutions to address unmet medical needs in
the acute care and oncology settings."
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 and received approval of the first supplemental NDA for
an expanded label in December
2021.
"Patients undergoing orthopedic procedures often experience
severe pain, slowing down their recovery time and potentially
leading to other complications. Reducing patients' pain within the
first three days is critical for patient satisfaction, and having a
product like ZYNRELEF now available for additional orthopedic
procedures is a great benefit to have in my practice," said
Alexander Sah, M.D., orthopedic
surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients
recover fully, be discharged sooner, and have significantly less
pain, with little to no opioid use."
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. ZYNRELEF was granted a marketing authorization by the
European Commission in September 2020
and by the United Kingdom Regulatory Authority in January 2021. In August
2023, we cancelled the ZYNRELEF U.K. marketing authorization
and, in October 2023, we cancelled
the ZYNRELEF European Union (EU) marketing authorization, as we do
not plan to commercially launch ZYNRELEF in the U.K. or the EU.
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, including, but not limited to, uncertainties
related to market conditions; the potential market opportunities
for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; the net product sales
guidance for the oncology care franchise and the acute care
franchise; the EBITDA guidance provided by the Company; the results
of the commercial launch of APONVIE; the potential additional
market opportunity for the approved expanded U.S. label for
ZYNRELEF; the timing of the Company's development of the VAN
program; the timing of the Company's submission of the PAS to the
FDA for the VAN; the timing of the FDA's review process and whether
the FDA approves the PAS for the VAN; the outcome of the Company's
pending ANDA litigation related to CINVANTI; 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; 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.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
View original content to download
multimedia:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-fda-approval-of-zynrelef-indication-expansion-to-include-additional-orthopedic-and-soft-tissue-procedures-302042620.html
SOURCE Heron Therapeutics, Inc.