FDA Approves Simparica^TM (sarolaner) Chewables

On Feb. 25, 2016, Zoetis received approval from the U.S. Food and Drug Administration (FDA) for Simparica^TM (sarolaner) Chewables to kill adult fleas and prevent flea infestations, as well as treat and control tick infestations due to the Lone Star tick, the Gulf Coast tick, the American dog tick, and the brown dog tick. Simparica is approved for use in dogs 6 months of age or older and weighing 2.8 pounds or more. In a single-dose, tasty chewable tablet, once-monthly Simparica offers fast and persistent protection from fleas and ticks, with peak performance that lasts for a full 35 days, without losing efficacy at the end of the month.¹

“Simparica is exciting for two reasons: it acts fast to kill fleas and ticks, and it maintains its efficacy all month long providing veterinarians and dog owners with confidence in continuous protection,” said Chris Adolph, DVM, DACVM (Parasitology), Zoetis. “Simparica kills fleas before they can reproduce and create a home infestation, and it kills ticks fast, which may help to reduce the likelihood of transferring pathogens that can cause tick-borne disease. Simparica continues to perform well, even on the last day of the month, whereas some of the other flea and tick products drop in efficacy at the end of their treatment period.”

“Simparica is the result of the collaboration of Zoetis scientists worldwide who share a commitment to develop innovative medicines that help address the most pressing needs of our veterinary customers and the animals in their care,” said Dr. Catherine Knupp, executive vice president and president, Research and Development at Zoetis. “We are excited to bring Simparica to veterinarians and dog owners in the United States.” 

The global market for antiparasitics in pets was over $4.2 billion in 2014, with a compound annual growth rate of 5% over the previous five years, driven largely by growth of new oral products, according to Vetnosis.²

Simparica: A New Ectoparasiticide from Zoetis

The active substance of Simparica is sarolaner, a new ectoparasiticide in the isoxazoline class, discovered and developed by Zoetis scientists. Simparica underwent extensive field safety and efficacy testing involving more than 900 dogs over a two- or three-month period. The dogs in these studies included both genders and many different breeds.¹

Clinical studies showed this isoxazoline started killing fleas in three hours, virtually eliminated fleas within eight hours, and it reduced the number of live fleas from ≥96.2% to 100% through day 35.¹ Simparica’s rapid onset of action means that fleas are killed before they have a chance to lay eggs,¹ preventing home infestations and providing relief to dogs suffering with flea allergy dermatitis.¹ Studies also showed that Simparica started killing ticks in eight hours,⁵ remaining ≥96.9% effective for 35 days against weekly re-infestations.^6-9

Simparica Killed Fleas Faster Than NexGard^®. In a comparative study, Simparica killed fleas faster than NexGard^® throughout the entire month. Simparica showed almost 100% flea kill eight hours after infestation, even at day 35, while NexGard^® started declining below 90% as early as day 21.⁴

Simparica Killed Ticks Faster Than NexGard^®.In a comparative study,Simparica killed ticks faster than NexGard^® throughout the entire month. Simparica maintained more than 90% effectiveness against the brown dog tick 24 hours after infestation at day 35, while efficacy for NexGard^® decreased to less than 80% by day 14.¹⁰

Simparica comes in a highly palatable liver-flavored chewable tablet. Zoetis expects to make Simparica available to veterinarians and pet owners in March 2016. The tablets will be available in 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg dosage strengths.  

For more information about Simparica and full Prescribing Information, visit: http://www.zoetisus.com/Simparica.

IMPORTANT SAFETY INFORMATION

Simparica is for use only in dogs, 6 months of age and older. Simparica may cause abnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and/or seizures. Simparica has not been evaluated in dogs that are pregnant, breeding or lactating. Simparica has been safely used in dogs treated with commonly prescribed vaccines, parasiticides and other medications. The most frequently reported adverse reactions were vomiting and diarrhea. See full Prescribing Information at www.zoetisUS.com/SimparicaPI.

References

1. Simparica (sarolaner) [package insert]. Kalamazoo, MI: Zoetis, Inc.; 2015.

2. Vetnosis, Animal Health Service: Parasiticides Report (Sept. 2015).

3. Zoetis. Overview of Clinical Safety in Client-Owned Dogs. 2015.

4. Zoetis. Comparative Speed of Kill of Sarolaner Administered Orally Against Induced Infestations of Ctenocephalides felis on Dogs (A160RZA-13-343, 2015).

5. Zoetis. Knock-down and Speed of Kill of Sarolaner Administered Orally Against Induced Infestations of Amblyomma maculatum on Dogs (A166C-US-13-318, 2014).

6. Zoetis. Dose Confirmation of Sarolaner Administered Orally Against Induced Infestations of Amblyomma maculatum on Dogs (A166C-US-12-128, 2014; A166C-US-12-129, 2014).

7. Zoetis. Dose Confirmation of Sarolaner Administered Orally Against Induced Infestations of Amblyomma americanum on Dogs (A166C-US-12-130, 2014; A166C-US-12-131, 2014).

8. Zoetis. Dose Confirmation of Sarolaner Administered Orally Against Induced Infestations of Dermacentor variabilis on Dogs (A166C-US-12-132, 2013; A166C-US-12-133, 2013).

9. Zoetis. Dose Confirmation of Sarolaner Administered Orally Against Induced Infestations of Rhipicephalus sanguineus on Dogs (A166C-US-12-135, 2013; A166C-IE-13-160, 2014; A166C-US-13-303, 2014; A166-AU-14-419, 2015).

10. Zoetis. Comparative Speed of Kill of Sarolaner Administered Orally Against Induced Infestations of Rhipicephalus sanguineus on Dogs (A162R-US-15-539, 2015).