SAN DIEGO, July 6, 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 that it has executed
a contract for ZYNRELEF with Apexus, LLC (Apexus). Apexus is the
designated Prime Vendor for the 340B
Drug Pricing Program. ZYNRELEF was approved by the U.S. Food and
Drug Administration (FDA) on May 12,
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. ZYNRELEF is the first and only extended-release
dual-acting local anesthetic and has been clinically shown to
better manage pain, including severe pain, compared to
standard-of-care bupivacaine over 72 hours and to significantly
reduce or eliminate opioid use in many patients following
surgery.
The 340B Drug Pricing Program
provides drug discounts to hospitals and clinics serving vulnerable
communities. The 340B Drug Pricing
Program allows 340B healthcare
providers to stretch limited federal resources to reduce the price
of outpatient pharmaceuticals for patients and expand health
services to the patients and communities they serve.
Under the agreement, Heron and the Prime Vendor Program, managed
by Apexus, will collaborate to lower drug pricing for participating
covered entities. The two organizations are working together to
assure that covered entities have access to safe and effective
non-opioid postoperative pain management.
"More than 90,000 Americans died of drug overdoses over the
12-month period that ended in September
2020, surpassing the yearly totals from any year since the
opioid epidemic began in the 1990s," said Barry Quart, Pharm.D.,
Chairman and Chief Executive Officer of Heron. "Ensuring ZYNRELEF
is widely available to healthcare providers at an affordable price
is a critical next to step to reducing exposure to opioids in the
surgical setting and to decreasing the number of unused opioids
available for potential misuse."
As the Prime Vendor, Apexus contracts with manufacturers and
distributors to help ensure access to discounted medications. Since
2004, the Prime Vendor Program has brought more than 40,000 covered
entities lower 340B drug pricing and
additional discounts for those who need it most.
"We are pleased to work alongside Heron to improve patient care
by increasing access to ZYNRELEF, a non-opioid option that has been
clinically shown to manage postoperative pain for up to 72 hours
after surgery," said Chris Hatwig,
President of Apexus.
Indication
ZYNRELEF is approved for use in adults to reduce pain for up to
3 days after removal of bunions, groin hernia repair, and total
knee replacement. ZYNRELEF is applied into the wound at the time of
surgery.
Important Safety Information
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.
- 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).
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
(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 on May 12, 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.
About Apexus
The 340B Prime Vendor Program,
managed by Apexus™, is a contract awarded by the Health Resources
and Services Administration (HRSA), which is responsible for
administering the 340B Drug Pricing
Program. As the Prime Vendor, Apexus contracts with manufacturers
and distributors to help ensure access to discounted medications,
provides 340B education to all
stakeholders, and helps support program integrity through technical
assistance.
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 potential market opportunity for ZYNRELEF
in the U.S.; 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.