- Simparica Trio marks the first all-in-one protection in the
U.S. against heartworm disease, ticks* and fleas, roundworms and
hookworms** in a single monthly chewable
- First parasiticide to combine sarolaner, moxidectin and
pyrantel
- First combination isoxazoline for dogs in the U.S.
- New product protects against many of the most common parasites
and gives veterinarians and pet owners a convenient option for
comprehensive protection
Zoetis today announced that the U.S. Food and Drug
Administration (FDA) has approved Simparica TrioTM (sarolaner,
moxidectin, and pyrantel chewable tablets), the first once-monthly,
chewable tablet in the U.S. that delivers all-in-one protection
from heartworm disease, ticks and fleas, roundworms and hookworms.
This combination product builds on the trusted legacy of Simparica®
(sarolaner) Chewables and exemplifies Zoetis’ dedication to
innovation in parasiticides.
“Today’s approval of Simparica Trio in the United States
provides veterinarians with a new and effective combination
parasiticide for dogs,” said Catherine A. Knupp, DVM, MS, Executive
Vice President and President, Research and Development at Zoetis.
“Combining the active ingredients sarolaner, moxidectin and
pyrantel delivers a convenient broad-spectrum option for
veterinarians to provide to dog owners. This innovation was
developed by a global team of Zoetis scientists and continues our
commitment to deliver new medicines that are needed by our
veterinary customers and the pets in their care.”
Studies that support the approval of Simparica Trio showed:
- 100% efficacy in preventing the development of heartworm
disease.
- ≥98.9% effectiveness against existing tick infestations ‡.
- Onset of kill for fleas at four hours and demonstrated 100%
efficacy at eight hours after initial administration.
- Efficacy against adult hookworms (>94%)+ and adult
roundworms (>99%)++.
“Comprehensive parasite protection is a critical component of
every annual wellness exam, and veterinarians should strongly
recommend year-round, broad-spectrum protection for all patients,”
said Chris Adolph, DVM, MS, Diplomate ACVM (Parasitology), Senior
Veterinary Specialist at Zoetis. “Simparica Trio makes it easier
for dog owners to follow their veterinarians’ recommendations for
parasite protection because it covers the most common parasites in
just one convenient chewable.”
Simparica Trio delivers on Zoetis’ commitment to innovation
in parasiticides
The introduction of Simparica Trio is just the latest example of
Zoetis’ commitment to next generation parasiticide products and
solutions for veterinarians, enabling them to provide the best
prevention and treatment options for pets. In addition to receiving
this approval, Zoetis has received approval for two parasiticide
innovations in the U.S. in the past 18 months to help protect dogs
and cats from harmful pests. ProHeart® 12 (moxidectin), which was
approved in July 2019, is the only once-yearly injection to prevent
heartworm disease in dogs 12 months of age and older. In November
2018, Zoetis received approval for Revolution® Plus (selamectin and
sarolaner topical solution), a combination topical product
providing 6-in-1 parasite protection against fleas, ticks***, ear
mites, roundworms, hookworms**** and heartworm disease for cats and
kittens as young as eight weeks of age and weighing 2.8 pounds or
greater.
Zoetis expects Simparica Trio to be available to veterinary
customers by mid-to-late April. Simparica Trio chewable tablets
will be available in six tablet strengths for dogs and puppies
eight weeks of age and older weighing at least 2.8 lbs.
For more information, visit www.SimparicaTrioDVM.com.
IMPORTANT SAFETY INFORMATION FOR SIMPARICA TRIO:
Use with caution in dogs with a history of seizures. Simparica
Trio contains sarolaner, a member of the isoxazoline class, which
has been associated with neurologic adverse reactions including
tremors, ataxia, and seizures in dogs with or without a history of
neurologic disorders. The safe use of Simparica Trio has not been
evaluated in breeding, pregnant, or lactating dogs. The most
frequently reported adverse reactions in clinical trials were
vomiting and diarrhea. See full Prescribing Information.
IMPORTANT SAFETY INFORMATION FOR SIMPARICA:
Simparica is for use only in dogs 6 months of age and older.
Simparica may cause neurologic signs such as tremors, unsteadiness
and/or seizures in dogs with or without a history of neurologic
disorders. Simparica has not been evaluated in pregnant, breeding
or lactating dogs. The most common adverse reactions in clinical
trials were vomiting and diarrhea. See full Prescribing
Information.
IMPORTANT SAFETY INFORMATION FOR PROHEART 12:
Use PROHEART 12 in dogs 12 months of age or older. Do not
administer to dogs that are sick, debilitated, underweight, have a
history of weight loss, or to those previously found to be
hypersensitive to the drug. Hypersensitivity reactions may occur in
some dogs when PROHEART 12 is administered alone or with vaccines.
Anaphylactic and anaphylactoid reactions can result in death and
should be treated immediately with the same measures used to treat
hypersensitivity reactions to vaccines and other injectable
products. The most common reported side effects in clinical trials
were vomiting, lethargy, diarrhea, and anorexia. People should
avoid inhalation, contact with eyes, or accidental self-injection.
Certification is required before veterinarians and staff administer
PROHEART 12. See full Prescribing Information.
IMPORTANT SAFETY INFORMATION FOR REVOLUTION PLUS:
The safe use of Revolution Plus has not been established in
kittens less than 8 weeks old or in breeding, pregnant or lactating
cats. Reported side effects in clinical trials included lethargy
and anorexia. Use with caution in cats with a history of neurologic
disorders. Sarolaner, one of the ingredients in Revolution Plus, is
a member of the isoxazoline class, which has been associated with
adverse reactions such as tremors, ataxia, and seizures. Reactions
have occurred in cats with or without a history of neurologic
disorders. In humans, Revolution Plus may be irritating to skin and
eyes. See full Prescribing Information.
About Zoetis
Zoetis is the leading animal health company, dedicated to
supporting its customers and their businesses. Building on more
than 65 years of experience in animal health, Zoetis discovers,
develops, manufactures and commercializes medicines, vaccines and
diagnostic products, which are complemented by biodevices, genetic
tests and precision livestock farming. Zoetis serves veterinarians,
livestock producers and people who raise and care for farm and
companion animals with sales of its products in more than 100
countries. In 2019, the company generated annual revenue of $6.3
billion with approximately 10,600 employees. For more information,
visit www.zoetis.com.
DISCLOSURE NOTICES
Forward-Looking Statements: This
press release contains forward-looking statements, which reflect
the current views of Zoetis with respect to business plans or
prospects, expectations regarding products, including timing of
shipments and other future events. These statements are not
guarantees of future performance or actions. Forward-looking
statements are subject to risks and uncertainties. If one or more
of these risks or uncertainties materialize, or if management's
underlying assumptions prove to be incorrect, actual results may
differ materially from those contemplated by a forward-looking
statement. Forward-looking statements speak only as of the date on
which they are made. Zoetis expressly disclaims any obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise. A further list and
description of risks, uncertainties and other matters can be found
in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, including in the sections thereof captioned
“Forward-Looking Statements and Factors That May Affect Future
Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on
Form 10-Q and in our Current Reports on Form 8-K. These filings and
subsequent filings are available online at www.sec.gov,
www.zoetis.com, or on request from Zoetis.
*Lone Star tick (Amblyomma americanum), Gulf Coast tick
(Amblyomma maculatum), American dog tick (Dermacentor variabilis),
black-legged or deer tick (Ixodes scapularis), and brown dog tick
(Rhipicephalus sanguineus)
**Roundworms (Toxocara canis and Toxacaris leonina) &
hookworms (Ancylostoma caninum and Uncinaria stenocephala)
‡ Simparica Trio demonstrated ≥99.4% effectiveness 72 hours
after treatment of existing Amblyomma americanum infestations
+Nemex-2 Package Insert
++Toxascaris leonina data derived from Nemex-2 clinical
studies
***Black-legged or deer tick, Gulf Coast tick, and American dog
tick
****Roundworm (Toxocara cati) & hookworm (Ancylostoma
tubaeforme)
All trademarks are the property of Zoetis Services LLC or a
related company or a licensor unless otherwise noted. © 2020 Zoetis
Services LLC. All rights reserved. STR-00054
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version on businesswire.com: https://www.businesswire.com/news/home/20200227005871/en/
Media Contacts: Colleen White
973-822-7203 colleen.white@zoetis.com
Christina Lood 973-822-7249 christina.lood@zoetis.com
Investor Contacts: Steve Frank
973-822-7141 steve.frank@zoetis.com
Marissa Patel 973-443-2996 marissa.patel@zoetis.com
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