SAN DIEGO, Oct. 4, 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 submission of a supplemental
New Drug Application (NDA) for ZYNRELEF (bupivacaine and meloxicam)
extended-release solution for an expanded indication.
ZYNRELEF is currently indicated 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. At a recent Type C meeting with the
U.S. Food and Drug Administration (FDA), Heron gained agreement on
the content of the supplement for expansion of the ZYNRELEF
indication statement to include foot and ankle, small–to–medium
open abdominal, and lower extremity total joint arthroplasty
surgical procedures without the need for additional clinical
studies. This submission is based on the consistent safety,
efficacy and pharmacokinetic data from previously completed
clinical trials.
Alignment was also reached with the FDA on the data needed to
support a future supplemental NDA to further expand the ZYNRELEF
indication statement to broadly include soft tissue and orthopedic
surgical procedures with pharmacodynamic, pharmacokinetic and
safety data from a limited number of additional procedures. The
studies in these additional surgeries are already in progress with
the plan to submit the next supplement in the second half of
2022.
"Our Type C meeting with the FDA was very positive, with
alignment on next steps for the submission of two sequential
supplemental NDAs designed to expand the ZYNRELEF indication
statement in a stepwise fashion. The first label expansion is
designed to significantly increase the annual number of indicated
surgical procedures and the second label expansion is anticipated
to broadly cover 14 million targeted surgical procedures.
Based on the strength of the clinical data already generated
with ZYNRELEF, the FDA agreed Heron could immediately submit the
first supplement, which we have done," said Barry Quart, Pharm.D.,
Chairman and Chief Executive Officer of Heron. "Submission of the
first supplement within three months of launching ZYNRELEF is a
major accomplishment, with the second supplement planned for next
year."
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
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
Warning.
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
ZYNRELEF.com.
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.
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, the timing of the FDA's review process and
whether the FDA approves the supplemental NDA for ZYNRELEF to
expand the U.S. label to related procedures; the potential
additional market opportunity for the expanded U.S. label; the
timing and results of studies for the further expansion of the U.S.
label for ZYNRELEF; 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:
David Szekeres
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.