Zoetis has announced that the European Commission has granted marketing authorization for Simparica™ Zoetis has announced that the European Commission has granted marketing authorization for Simparica™ (sarolaner) chewable tablets, a once-monthly medication for the treatment of fleas, ticks and sarcoptic mange in dogs beginning at eight weeks of age. 

Dr. Balázs Capári, a Hungarian veterinary specialist in small animal medicine who participated in clinical trials of Simparica said: "The approval of Simparica gives veterinarians a new oral choice in parasite control for dogs. In my experience, Simparica  has been shown to rapidly kill fleas and ticks with efficacy that persists for five weeks. Dog owners participating in the trials also reported that Simparica is very palatable; the chewable tablet was easily taken by their dogs. The convenience of a once monthly chewable tablet helps increase compliance with treatment, giving veterinarians and dog owners confidence in continuous protection."

Dr. Catherine Knupp, Executive Vice President and President, Research and Development at Zoetis, said: "At Zoetis, we focus our innovation on the most pressing needs of veterinarians, and that is what guided us to develop a new oral choice to provide dogs with persistent protection from fleas and ticks and treatment of mites that cause sarcoptic mange. Simparica is a result of the collaboration of Zoetis scientists worldwide, who share a determination to develop new medicines that deliver real value to our veterinary customers and the animals in their care. We are excited to bring this innovative medicine, Simparica, to veterinarians and dog owners across Europe." 

The active substance of Simparica is sarolaner, a new ectoparasiticide in the isoxazoline class, developed by Zoetis.

Zoetis says the marketing authorization for Simparica was based on the results of field studies conducted in seven countries, involving more than 800 dogs of various breeds from at least eight weeks of age and 1.3 kg of weight. Simparica was shown to provide efficacy for at least five weeks against ticks and fleas. It demonstrated a rapid onset of action, killing fleas before they have a chance to lay eggs and can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis. It proved effective in treating sarcoptic mange, a highly contagious skin disease in dogs.

In studies, Simparica killed all four species of tick dominant in Europe (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus) and species of flea that most frequently infect dogs in European countries (Ctenocephalides felis and Ctenocephalides canis). Simparica was well tolerated with no adverse events reported at the therapeutic dose.

Zoetis expects to launch Simparica in the EU in the first quarter of 2016. Simparica chewable tablets will be available in 5mg, 10mg, 20mg, 40mg and 80mg dosage strengths.    

For more information about Simparica and full prescribing information, visit http://www.zoetis.com/products-services/companion-animals/dogs.

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