Topical Treatment for Fleas and Ticks
Effective for up to 12 Weeks
Merck Animal Health, known as MSD Animal Health outside of the
United States and Canada, today announced the U.S. Food and Drug
Administration’s approval of BRAVECTO® (fluralaner topical
solution) for both cats and dogs, a topical treatment for fleas and
ticks effective for up to 12 weeks1,2 following a single dose.
“The approval of a second BRAVECTO product builds on the strong
foundation and body of scientific evidence that we have established
with our chewable tablet for dogs, our oral flea and tick product,”
said KJ Varma, senior vice president, research and development,
Merck Animal Health. “With BRAVECTO Topical, we have expanded our
portfolio in the fight against parasites, as well as provided cats
flea and tick protection that delivers immediate and persistent
killing activity for 12 weeks – another first in the industry.”
BRAVECTO Topical is available in a convenient, single-dose
spot-on, and is applied topically using the new “Twist’n’Use”TM
pipette design for ease of application. BRAVECTO Topical for dogs
kills adult fleas and is indicated for the treatment and prevention
of flea infestations (Ctenocephalides felis) and the treatment and
control of tick infestations [Ixodes scapularis (black-legged
tick), Dermacentor variabilis (American dog tick),and Rhipicephalus
sanguineus (brown dog tick)] for 12 weeks in dogs and puppies six
months of age and older, and weighing 4.4 pounds or greater. It is
also indicated for the treatment and control of Amblyomma
americanum (lone star tick) infestations for eight weeks in dogs
and puppies six months of age and older, and weighing 4.4 pounds or
greater.
BRAVECTO Topical for cats kills adult fleas and is indicated for
the treatment and prevention of flea infestations (Ctenocephalides
felis) and the treatment and control of Ixodes scapularis
(black-legged tick) infestations for 12 weeks in cats and kittens
six months of age and older, and weighing 2.6 pounds or greater. It
is also indicated for the treatment and control of Dermacentor
variabilis (American dog tick) infestations for eight weeks in cats
and kittens six months of age and older and weighing 2.6 pounds or
greater.
“Fleas and ticks are not simply a nuisance, but can also cause
significant irritation to our pets and even ourselves, and can
transmit disease. So, effective protection against these parasites
is truly essential to the health and well-being of our pets, as
well as our homes,” said Kathleen Heaney, D.V.M., executive
director of technical services, Merck Animal Health. “The
convenience of BRAVECTO’s extended duration flea and tick
protection is now available for cats and dogs in a topical
formulation that is fast-acting and lasts nearly three times longer
than conventional, monthly flea and tick products.”1,2
Fleas and ticks must attach to the treated animal and commence
feeding in order to be exposed to the active substance. The active
substance of BRAVECTO, fluralaner, an ectoparasiticide belonging to
the isoxazoline group, is systemically active against fleas and
ticks. The product can be used as part of a treatment strategy for
the control of Flea Allergy Dermatitis (FAD) as a direct result of
eliminating flea infestations.
BRAVECTO products are only available through licensed
veterinarians. BRAVECTO Topical for cats is expected to be
available later in 2016. The dog topical product is expected to be
available in the first quarter of 2017.
Important Safety Information (Cats):
The most common adverse reactions recorded in clinical trials
were vomiting, itching, diarrhea, hair loss, decreased appetite,
lethargy, and scabs/ulcerated lesions. Bravecto has not been shown
to be effective for 12-weeks' duration in kittens less than 6
months of age. Bravecto is not effective against American dog ticks
beyond 8 weeks of dosing. For topical use only. Avoid
oral ingestion. The safety of Bravecto has not been established in
breeding, pregnant and lactating cats. Use with caution in cats
with a history of neurologic abnormalities. Neurologic
abnormalities have been reported in cats receiving Bravecto, even
in cats without a history of neurologic abnormalities.
Important Safety Information (Dogs):
The most common adverse reactions recorded in clinical trials
were vomiting, hair loss, diarrhea, lethargy, decreased appetite,
and moist dermatitis/rash. Bravecto has not been shown to be
effective for 12-weeks' duration in puppies less than 6 months of
age. Bravecto is not effective against lone star ticks beyond
8 weeks of dosing. For topical use only. Avoid oral ingestion.
Use with caution in dogs with a history of seizures. Seizures have
been reported in dogs receiving fluralaner, even in dogs without a
history of seizures.
Click to view the U.S. Prescribing Information for BRAVECTO
Topical Solution for cats and BRAVECTO Topical Solution for
dogs.
About Merck Animal Health
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck Animal Health, known as
MSD Animal Health outside the United States and Canada, is the
global animal health business unit of Merck (NYSE:MRK). Through its
commitment to the Science of Healthier Animals™, Merck Animal
Health offers veterinarians, farmers, pet owners and governments
one of the widest range of veterinary pharmaceuticals, vaccines and
health management solutions and services. Merck Animal Health is
dedicated to preserving and improving the health, well-being and
performance of animals. It invests extensively in dynamic and
comprehensive R&D resources and a modern, global supply chain.
Merck Animal Health is present in more than 50 countries, while its
products are available in some 150 markets. For more information,
visit www.merck-animal-health.com or connect with us on
LinkedIn and Twitter at @MerckAH.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2015
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
1 BRAVECTO Topical for cats is not effective against Dermacentor
variabilis ticks beyond 8 weeks after dosing.
2 BRAVECTO Topical for dogs is not effective against Amblyomma
americanum ticks beyond 8 weeks after dosing.
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Merck Animal HealthMedia:Kelly Goss,
913-558-6452kelly.goss@merck.comorPamela Eisele,
267-305-3558pamela.eisele@merck.comorInvestor Relations:Amy Klug,
908-740-1898amy.klug@merck.com
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