SAN DIEGO, Oct. 22, 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 recommended dosage to include the 130 mg single-dose regimen
for patients receiving MEC.
CINVANTI is the first and only IV formulation of a substance
P/neurokinin-1 (NK1) receptor antagonist (RA) that
is free of synthetic surfactants, including polysorbate 80, and
that is approved for use as a 2-minute IV injection (also referred
to as an IV push). CINVANTI is indicated for the prevention of
acute and delayed chemotherapy-induced nausea and
vomiting (CINV) following both highly emetogenic cancer
chemotherapy (HEC) and MEC. 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 HEC and 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. In
February 2019, the FDA approved
Heron's sNDA to expand the administration of CINVANTI beyond the
already approved administration method (a 30-minute IV infusion) to
include a 2-minute IV injection (also referred to as an IV push).
This 2-minute IV push for CINVANTI was approved based on a third
study demonstrating bioequivalence and a comparable safety profile
to CINVANTI given as a 30-minute IV infusion.
The CINVANTI label expansion standardizes the CINVANTI 130 mg
single-dose regimen for patients receiving HEC and/or MEC as an
injection over 2 minutes or an infusion over 30 minutes, further
simplifying dosing and administration and eliminating the need to
take oral aprepitant on Days 2 and 3 following MEC administration.
Furthermore, this label expansion builds on the prior label
expansion that introduced the 2-minute IV push, which enables
physicians to leverage the operational advantages of this method of
administration and contributes to a reduction in total patient time
spent at the infusion site.
"This most recent label expansion to offer a simplified dosing
regimen for MEC adds to the important advantages CINVANTI provides
to patients as the only FDA-approved, IV NK1 RA
available as a convenient 2-minute IV push for MEC and HEC," said
Rudolph M. Navari, M.D., Ph.D.,
University of Alabama, Birmingham
School of Medicine, Division of Hematology and Oncology. "The
simplified dosing in MEC removes the need for patients to take oral
aprepitant on Days 2 and 3, which can improve compliance and reduce
costs. These benefits continue to improve the overall patient
experience with CINVANTI."
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 HEC,
including high-dose cisplatin, and nausea and vomiting associated
with initial and repeat courses of MEC. 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 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).
The FDA-approved dosing administration included in the
United States prescribing information for CINVANTI is a
30-minute IV infusion or a 2-minute IV 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 of CINVANTI 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 CINVANTI.
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 reinitiate 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 are:
- Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea,
neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia,
dyspepsia, urinary tract infection, pain in extremity.
- 3-day oral aprepitant with MEC (≥1% and greater than standard
therapy): fatigue and eructation.
- Single-dose fosaprepitant with HEC: generally similar to 3-day
oral aprepitant. In addition, infusion site reactions (3%)
occurred.
- Single-dose CINVANTI (≥2%): 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; 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.