SAN
DIEGO, Oct. 10, 2024 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a
commercial-stage biotechnology company, today reaffirmed the
Company's ability to supply CINVANTI® (aprepitant)
injectable emulsion and SUSTOL® (granisetron)
extended-release injection for Chemotherapy Induced Nausea and
Vomiting ("CINV") prevention and APONVIE® for
Postoperative Nausea and Vomiting ("PONV") prevention given the
temporary shortage of intravenous ("IV") fluids which is expected
as the result of Hurricane Helene. As alternatives to products that
require dilution with IV fluids, CINVANTI, SUSTOL, and APONVIE are
supplied in ready-to-administer formulations that do not
require additional dilution with IV fluids in what may be a
time of critical shortage.
As widely reported, the potential disruption in the supply of
intravenously administered fluids is a result of the temporary
closure of a major suppliers' manufacturing site in Marion, North Carolina which was impacted by
Hurricane Helene. The Marion
facility is believed to supply up to 60% of the IV fluid market in
the U.S.
"In the wake of Hurricane Helene, and with the recently
announced potential supply disruption for IV fluids, Heron has
received outreach from several health systems preparing to maintain
continuity of care," said Craig Collard, Chief Executive
Officer of Heron. "Our team is committed to ensuring timely
delivery of our products throughout the U.S. during the potential
shortage of IV fluids as we understand the importance of preventing
CINV and PONV for both patients and providers."
CINVANTI, SUSTOL, and APONVIE are available through major
wholesalers and specialty distributors, and further information can
be obtained by calling the Company's information line at
844-HERON11 (844-437-6611).
About CINVANTI for Chemotherapy Induced Nausea and Vomiting
(CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is
indicated in adults for the prevention of acute and delayed nausea
and vomiting associated with initial and repeat courses of highly
emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
as a single-dose regimen, delayed nausea and vomiting associated
with initial and repeat courses of moderately emetogenic cancer
chemotherapy (MEC) as a single-dose regimen, and nausea and
vomiting associated with initial and repeat courses of MEC as a
3-day regimen. CINVANTI is an IV formulation of aprepitant, an
NK1 RA. CINVANTI is the first IV formulation to directly
deliver aprepitant, the active ingredient in EMEND® capsules.
Aprepitant (including its prodrug, fosaprepitant) is a single-agent
NK1 RA to significantly reduce nausea and vomiting in
both the acute phase (0–24 hours after chemotherapy) and the
delayed phase (24–120 hours after chemotherapy). The FDA-approved
dosing administration included in the U.S. prescribing information
for CINVANTI include 100 mg or 130 mg administered as a 30-minute
IV infusion or a 2-minute IV injection.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL for CINV Prevention
SUSTOL is indicated in combination with other antiemetics in
adults for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
chemotherapy (MEC) or anthracycline and cyclophosphamide (AC)
combination chemotherapy regimens. SUSTOL is an extended-release,
injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's
Biochronomer® drug delivery technology to maintain therapeutic
levels of granisetron for ≥5 days. The SUSTOL global Phase 3
development program was comprised of two, large, guideline-based
clinical studies that evaluated SUSTOL's efficacy and safety in
more than 2,000 patients with cancer. SUSTOL's efficacy in
preventing nausea and vomiting was evaluated in both the acute
phase (0–24 hours after chemotherapy) and delayed phase (24–120
hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
About APONVIE for Postoperative Nausea and Vomiting
(PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated
for the prevention of PONV in adults. Delivered via a 30-second IV
push, APONVIE 32 mg was demonstrated to be bioequivalent to oral
aprepitant 40 mg with rapid achievement of therapeutic drug levels.
APONVIE is the same formulation as Heron's approved drug product
CINVANTI. APONVIE is supplied in a single-dose vial that delivers
the full 32 mg dose for PONV. APONVIE was approved by the FDA in
September 2022 and became
commercially available in the U.S. on March
6, 2023.
Please see full prescribing information at www.APONVIE.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
APONVIE®, CINVANTI® and
SUSTOL®. 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.
