-The U.S. Food and Drug Administration ("FDA")
assigned a Prescription Drug User Fee Act ("PDUFA") goal date of
September 23, 2024
SAN
DIEGO, July 2, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a
commercial-stage biotechnology company, today announced that the
FDA acknowledged the receipt of the Company's Prior Approval
Supplement ("PAS") application for ZYNRELEF®
(bupivacaine and meloxicam) extended-release solution VAN. The FDA
has assigned a PDUFA goal date of September
23, 2024.
If approved, the introduction of 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 from up to three minutes 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. If approved, the VAN is
expected to be available for use in the fourth quarter of this
year.
In addition to the anticipated launch of the VAN, the national
rollout of the CrossLink Life Sciences, LLC ("CrossLink")
partnership continues to make progress and is expected to add ~650
representatives to the promotion of ZYNRELEF by year-end. The
Company anticipates that this partnership will be instrumental in
successfully launching the VAN to a large base of orthopedic
surgeons across the country.
"The acknowledgement of the VAN submission and corresponding
designation of a four-month review for ZYNRELEF is exciting and we
look forward to working with the FDA during the application review
process," said Craig Collard, Chief
Executive Officer at Heron. "With the continued integration of
CrossLink and the launch of the VAN, we are optimistic about the
potential for more accounts to adopt ZYNRELEF as an essential part
of their 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, including any potential delays in the
anticipated PDUFA goal date; our 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; and 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.
