SAN DIEGO, Feb. 26, 2019 /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 the U.S. Food and Drug
Administration (FDA) has approved Heron's supplemental New
Drug Application (sNDA) for CINVANTI (aprepitant) injectable
emulsion, for intravenous (IV) use. The sNDA requested FDA approval
to expand the administration of CINVANTI beyond the already
approved administration method (a 30-minute IV infusion) to include
a 2-minute IV injection.
CINVANTI is the first and only polysorbate 80-free, IV
formulation of an NK1 receptor antagonist (RA) indicated
for the prevention of acute and delayed chemotherapy-induced nausea
and vomiting (CINV). CINVANTI is the first IV formulation to
directly deliver aprepitant, the active ingredient in
EMEND® capsules. Aprepitant (including its prodrug,
fosaprepitant) is the only single-agent NK1 RA to
significantly reduce CINV in both the acute phase (0 – 24 hours
after chemotherapy) and the delayed phase (24 – 120 hours after
chemotherapy).
CINVANTI was initially approved based on data demonstrating the
bioequivalence of CINVANTI to EMEND
IV® (fosaprepitant), supporting its efficacy for
the prevention of acute and delayed CINV following highly
emetogenic cancer chemotherapy (HEC) and moderately emetogenic
cancer chemotherapy (MEC). Results from two pivotal, randomized,
cross-over, bioequivalence studies of CINVANTI and EMEND IV showed
subjects receiving CINVANTI reported fewer adverse events than
those receiving EMEND IV, including substantially fewer
infusion-site reactions.
The new method of administration for CINVANTI was approved based
on a third study demonstrating bioequivalence and a comparable
safety profile for CINVANTI given as a 30-minute IV infusion and as
a 2-minute IV injection, also referred to as an IV push.
"CINVANTI, delivering the efficacy of aprepitant, but without
polysorbate 80, has been an important addition for the prevention
of CINV. Notably, data now show that the 2-minute IV push has
comparable safety to the 30-minute IV infusion. This approval will
enable physicians to leverage the operational advantages of this
method of administration and will contribute to a reduction in
total patient time spent in the infusion suite," said Rudolph M. Navari, M.D., Ph.D., University of Alabama, Birmingham School of
Medicine, Division of Hematology Oncology.
"We are pleased to have strengthened our CINV franchise with
today's label expansion for CINVANTI, as we now have the only
NK1 RA that offers the benefits and flexibility of an IV
push method of administration," said Barry Quart, Pharm.D.,
President and Chief Executive Officer of Heron. "Administration of
CINVANTI by 2-minute IV push is an important advantage for our
customers compared to EMEND IV, which requires reconstitution and
an IV bag for infusion."
About CINVANTI (aprepitant) injectable emulsion
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, and nausea and vomiting associated with initial and
repeat courses of moderately emetogenic cancer chemotherapy (MEC).
CINVANTI is an IV formulation of aprepitant, a substance
P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI
is the first IV formulation to directly deliver aprepitant, the
active ingredient in EMEND® capsules. Aprepitant
(including its prodrug, fosaprepitant) is the only 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). CINVANTI is the
only IV formulation of an NK1 RA indicated for the
prevention of acute and delayed nausea and vomiting associated with
HEC and nausea and vomiting associated with MEC that is free
of polysorbate 80 or any other synthetic surfactant. The
FDA-approved dosing administration included in the United States prescribing information for
CINVANTI is a 30-minute infusion or a 2-minute injection.
Please see full prescribing information at www.CINVANTI.com.
Important Safety Information
Contraindications
CINVANTI is contraindicated in patients with hypersensitivity to
any of the components of CINVANTI.
Concurrent use of pimozide with CINVANTI is contraindicated.
Warnings and Precautions
Clinically Significant CYP3A4 Drug Interactions
Aprepitant is a substrate, weak-to-moderate (dose-dependent)
inhibitor, and an inducer of CYP3A4.
- Use with other drugs that are CYP3A4 substrates may result in
increased plasma concentration of the concomitant drug.
-
- Use of pimozide with CINVANTI is contraindicated due to the
risk of significantly increased plasma concentrations of pimozide,
potentially resulting in prolongation of the QT interval, a known
adverse reaction of pimozide.
- Use of CINVANTI with strong or moderate CYP3A4 inhibitors
(e.g., ketoconazole, diltiazem) may increase plasma concentrations
of aprepitant and result in an increased risk of adverse reactions
related to CINVANTI.
- Use of CINVANTI with strong CYP3A4 inducers (e.g., rifampin)
may result in a reduction in aprepitant plasma concentrations and
decreased efficacy of aprepitant.
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis
during or soon after administration of CINVANTI have occurred.
Symptoms including dyspnea, eye swelling, flushing, pruritus, and
wheezing have been reported. If hypersensitivity reactions occur,
discontinue CINVANTI. Do not reinstate CINVANTI in patients who
experience these symptoms with previous use.
Decrease in INR with Concomitant Warfarin
Co-administration of CINVANTI with warfarin, a CYP2C9
substrate, may result in a clinically significant decrease in the
International Normalized Ratio (INR) of prothrombin time. Monitor
the INR in patients on chronic warfarin therapy in the 2-week
period, particularly at 7 to 10 days, following initiation of
CINVANTI with each chemotherapy cycle.
Risk of Reduced Efficacy of Hormonal Contraceptives
The efficacy of hormonal contraceptives may be reduced
during administration of and for 28 days following the last dose of
CINVANTI. Advise patients to use effective alternative or back-up
methods of non-hormonal contraception during treatment with
CINVANTI and for 1 month following administration of CINVANTI or
oral aprepitant, whichever is administered last.
Use in Specific Populations
Avoid use of CINVANTI in pregnant women as alcohol is an
inactive ingredient for CINVANTI. There is no safe level of alcohol
exposure in pregnancy.
Adverse Reactions
The most common adverse reactions with the 3-day oral aprepitant
regimen in conjunction with MEC (≥1% and greater than standard
therapy) were fatigue and eructation.
The most common adverse reactions with the single-dose
intravenous fosaprepitant regimen in conjunction with HEC were
generally similar to that seen in prior HEC studies with oral
aprepitant. In addition, infusion site reactions (3%) occurred.
The most common adverse reactions with single-dose CINVANTI
(≥2%) were headache and fatigue. The safety profile of CINVANTI in
healthy subjects who received a single 2-minute injection was
similar to that seen with a 30-minute infusion.
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. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents for patients suffering from
pain or cancer.
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, those associated with: the commercial
opportunity for CINVANTI IV push; 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
Senior VP, General Counsel, Business Development and Corporate
Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.