title: Evaluation of the effectiveness of a novel oral formulation of sarolaner (Simparica™) for the treatment and control of fleas on dogs.
abstract: The efficacy of a single oral dose of a novel isoxazoline, sarolaner (Simparica™, Zoetis), for the treatment and control of flea infestations on dogs was confirmed in five laboratory studies. The studies were conducted using adult purpose-bred Beagles and/or mixed breed dogs. All animals were individually identified and housed, and were allocated randomly to treatment with either placebo or sarolaner (eight to 10 per group) based on pretreatment parasite counts. Three studies used cat flea (Ctenocephalides felis felis) strains recently isolated from the field from the US, EU, or Australia; in the fourth study a laboratory strain (KS1) with documented tolerance to a number of insecticides such as fipronil, imidacloprid, and permethrin was used. In the fifth study, dogs were infested with dog fleas, Ctenocephalides canis. Dogs were treated orally on Day 0 with a placebo or a sarolaner tablet providing a minimum dose of 2mg/kg. Dogs were infested with approximately 100 unfed, adult fleas prior to treatment and at weekly intervals post-treatment. Comb counts were conducted to determine the numbers of viable fleas at 24h after treatment and after each subsequent infestation. Efficacy against C. felis and C. canis was 99.8-100% from treatment through Day 35. In all five studies, elimination of existing infestations was achieved within 24h after dosing, with only a single live C. felis found on one dog on Day 1. Similarly, control of flea challenges was achieved within 24h after infestation throughout the 35day study periods, with only single live C. felis found on two dogs on Day 28 in one study, and on a single dog on Day 35 in another study. There were no adverse reactions to treatment with sarolaner. These studies confirmed that a single oral dose of sarolaner at 2mg/kg provided highly effective treatment of existing C. felis infestations and persistent control of C. felis on dogs for 35days after treatment. Efficacy equivalent to that seen with C. felis was confirmed against C. canis and a known insecticide-tolerant strain of C. felis.
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 333 Portage St. Kalamazoo, MI 49007, USA. Electronic address: robert.six@Zoetis.com.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Six
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, Hoge Wei 10, B-1930 Zaventem, Belgium.
authors.forename: Thomas
authors.initials: T
authors.lastname: Geurden
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 45 Poplar Road, Parkville, VIC 3052, Australia.
authors.forename: Raj
authors.initials: R
authors.lastname: Packianathan
authors.affiliation: SCEC Pty Ltd., P.O. Box 211, Northbridge, NSW 1560, Australia.
authors.forename: Sally
authors.initials: S
authors.lastname: Colgan
authors.affiliation: BerTek, Inc., P.O. Box 606, Greenbrier, AR 72058, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Everett
authors.affiliation: Charles River Laboratories, Pre-Clinical Services, Glenamoy, Co., Mayo, Ireland.
authors.forename: Sarah
authors.initials: S
authors.lastname: Grace
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 45 Poplar Road, Parkville, VIC 3052, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hodge
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 333 Portage St. Kalamazoo, MI 49007, USA.
authors.forename: Sean P
authors.initials: SP
authors.lastname: Mahabir
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 333 Portage St. Kalamazoo, MI 49007, USA.
authors.forename: Melanie R
authors.initials: MR
authors.lastname: Myers
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, Hoge Wei 10, B-1930 Zaventem, Belgium.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Slootmans
authors.affiliation: Zoetis, Veterinary Medicine Research and Development, 45 Poplar Road, Parkville, VIC 3052, Australia.
authors.forename: Kylie
authors.initials: K
authors.lastname: Davis
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004283:Dog Diseases / Q000188:drug therapy* / Q000517:prevention & control; D004285:Dogs; D004339:Drug Compounding / Q000592:standards / Q000662:veterinary*; D005260:Female; D058267:Flea Infestations / Q000188:drug therapy / Q000517:prevention & control / Q000662:veterinary*; D007306:Insecticides / Q000008:administration & dosage / Q000592:standards; D007555:Isoxazoles / Q000008:administration & dosage* / Q000592:standards*; D008297:Male; D016896:Treatment Outcome
chemical_list: D007306:Insecticides; D007555:Isoxazoles
keywords: Ctenocephalides canis; Ctenocephalides felis felis; Dog; Dose confirmation; Flea; Isoxazoline; KS1; Oral; Sarolaner