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Afoxolaner, an insecticide and acaricide compound of the isoxazoline class, is available for dogs as an oral ectoparasiticide medicine (NexGard®) and as an oral endectoparasiticide medicine in combination with milbemycin oxime (MO), a macrocyclic lactone (NexGard® Spectra). The safety of these two compounds, alone or in combination, was investigated in homozygous MDR1-deficient collie dogs, in two studies. Overall, 30 adult collie dogs were treated once orally, 9 with a placebo, 9 with afoxolaner, 6 with MO, and 6 with a combination of afoxolaner and MO. For afoxolaner, the mean investigated dosage corresponded to 3.8 and 4.7 multiples of the maximum recommended therapeutic doses (RTD) in NexGard® and NexGard® Spectra, respectively. For MO, the mean investigated dosage corresponded to 4.7 multiples of the maximum RTD in NexGard® Spectra. Dogs were closely monitored for adverse reactions on the day of treatment and for the following two days. No significant adverse reaction was observed in any dog from the afoxolaner or the afoxolaner + MO groups; in the MO-only treated group, mild and transient neurological signs were observed during the 4-8 h post-treatment window. These studies demonstrated a high level of safety of oral afoxolaner, alone or in combination with milbemycin oxime, in homozygous MDR1-deficient dogs.

The safety profile of NexGard®Combo, a novel topical product for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment and prevention of internal and external parasites, was evaluated in kittens, in two margin-of-safety studies (Studies #1 and #2), and in an oral tolerance study (Study #3). In the margin of safety studies, kittens were dosed several times topically with multiples of the maximum exposure dose (1×): in Study #1, 3× and 5× doses four times at 2-week intervals; in Study #2, 1×, 3× and 5× doses six times at 4-week intervals. In Study #3, kittens were dosed orally once with a 1× dose. Furthermore, in Study #1, another group of kittens was dosed topically twice at a 4-week interval with a formulation of esafoxolaner as the sole active ingredient dosed at 23×. Physical examinations and clinical pathology analyses were performed throughout the studies, followed by necropsy and detailed histopathological evaluation in Studies #1 and #2. No significant treatment related effects were observed in the three studies, except for one occurrence of reversible neurological signs attributed to eprinomectin in one cat after the third 5× dose in Study #2, with clinical signs observed nine hours after dosing, pronounced for a few hours, significantly improved the next day, and absent 2 days after dosing. In conclusion, NexGard®Combo was demonstrated safe in kittens following repeated topical administrations and following oral ingestion, and very high topical doses of esafoxolaner were well tolerated.

Esafoxolaner, a purified enantiomer of afoxolaner with insecticidal and acaricidal properties, is combined with eprinomectin and praziquantel in NexGard®Combo, a novel topical endectoparasiticide formulation for cats. The parasiticide potencies of topical esafoxolaner, eprinomectin and praziquantel, are based on transcutaneous absorption, systemic distribution, and exposure of respective target parasites. For each compound, the pharmacokinetic profile, non-interference, dose linearity/proportionality after one administration, and the accumulation and time to reach a steady state after repeated monthly administrations of the novel formulation, were investigated. After one topical application of NexGard®Combo at the minimum recommended dose, the mean plasma concentration of esafoxolaner immediately reached (and remained at) a level supporting rapid onset and sustained efficacy against ectoparasites for at least 1 month. The meanCmax,Tmax,T1/2, and the topical bioavailability of esafoxolaner were 130 ng/mL, 7.1 days, 21.7 days and 47.2%, respectively, and the plasma profiles of eprinomectin and praziquantel supported their known endoparasiticide properties. No relevant interference between the three compounds was observed. Dose proportionality was demonstrated for the three compounds over a range of 0.5× to 2× the minimum recommended dose. Steady state after repeated monthly administrations was reached by the second dose for praziquantel and by the fifth dose for esafoxolaner and eprinomectin. Accumulation was limited and drug plasma concentrations were maintained within a safe level.

Esafoxolaner is a purified enantiomer of afoxolaner with insecticidal and acaricidal properties. It is combined with eprinomectin and praziquantel in a novel topical endectoparasiticide formulation for cats. The efficacy of this novel formulation was assessed in an experimental study against induced infestation of Rhipicephalus sanguineus ticks. Twenty cats were randomly allocated to either a placebo control group or a treated group in a 1:1 ratio. Infested cats were treated topically once at the minimum recommended dose. The study was designed to assess curative efficacy 48 h after treatment and to test preventive efficacy 48 h after weekly infestations for 2 months. At each weekly infestation, all cats were infested with 25 male and 25 unfed female R. sanguineus ticks. At each tick count, at least 6 in 10 control cats had a retention of 13 (26%) or more live ticks, demonstrating adequate infestation throughout the study. Curative efficacy on existing tick infestation was 90%; preventive efficacy over the following 6 weeks was at least 96%.Efficacité d’une nouvelle association topique d’esafoxolaner, d’éprinomectine et de praziquantel contre Rhipicephalus sanguineus chez le chat.L'esafoxolaner est un énantiomère purifié d’afoxolaner, aux propriétés insecticides et acaricides. Il est combiné à éprinomectine et praziquantel dans une nouvelle formulation topique endectoparasiticide pour chats. L’efficacité de cette nouvelle formulation a été testée lors d’une étude contre des infestations expérimentales avec des tiques Rhipicephalus sanguineus. Vingt chats ont été répartis au hasard soit dans un groupe témoin placebo soit dans un groupe traité (rapport 1:1). Les chats infestés ont été traités par voie topique une fois à la dose minimale recommandée. L’étude a été conçue pour une évaluation de l’efficacité curative 48 heures après traitement et pour des évaluations d’efficacité préventive 48 heures après chaque infestation hebdomadaire pendant 2 mois. À chaque infestation hebdomadaire, tous les chats étaient infestés par 25 mâles et 25 femelles de R. sanguineus, non nourris. À chaque comptage, au moins 6 chats sur 10 du groupe placebo contrôle étaient infestés avec au moins 13 (26 %) tiques vivantes, ce qui a validé le modèle d’infestation. L’efficacité curative sur tiques présentes avant traitement a été de 90 %, l’efficacité préventive durant les six semaines suivantes a été d’au moins 96 %.

NexGard® Combo is a novel topical endectoparasiticide formulation for cats combining the insecticide/acaricide esafoxolaner, the nematodicide eprinomectin and the cestodicide praziquantel. The efficacy of this novel formulation for the prevention of heartworm disease in cats was tested in two experimental studies using an induced infection model and a randomized, blinded, placebo-controlled study design, and two USA isolates of Dirofilaria immitis. In each study, 20 naïve cats were each inoculated sub-cutaneously with 100 third-stage larvae of D. immitis 30 days before treatment. Following randomization to two treatment groups of ten cats, each cat was treated topically once, either with the minimum recommended dose of the novel formulation, or with an identical volume of placebo. Five months after treatment (6 months after infections), the cats were humanely euthanized for parasite recovery and count. Efficacy was calculated by comparison of the numbers of adult D. immitis recovered in the control and in the novel formulation groups. In the control groups of each study, D. immitis were recovered in seven and nine cats (respective worm counts ranges 1–7 and 1–16, respective geometric means 1.6 and 5.1). In both studies, none of the treated cats harbored any D. immitis at necropsy and the calculated efficacy of the novel formulation was 100%. There were no adverse reactions related to treatment with the novel formulation. The results of these two studies demonstrate that a topical NexGard® Combo application at the minimum label dose is well-tolerated and efficacious in preventing heartworm disease in cats.

Esafoxolaner, a purified enantiomer of afoxolaner with insecticidal and acaricidal properties, is combined with eprinomectin and praziquantel in NexGard® Combo, a novel topical endectoparasiticide formulation for cats. The efficacy of this novel formulation against adult and immature stages of Ctenocephalides felis fleas was tested in four experimental studies. Two studies were designed to test adulticide efficacy, one to test inhibition of immature stages, and one to test both adulticide efficacy and inhibition of immature stages. In each study, cats were randomly allocated to a placebo control group or to a novel formulation group treated once at the minimum recommended dose. Cats were experimentally infested weekly for one to two months with unfed C. felis originating from North America or Europe. For adulticide efficacy evaluations, live fleas were counted 24 h after treatment and after subsequent weekly infestations. For immature stages, flea eggs were collected and counted weekly for evaluation of egg production inhibition and incubated for larval hatching evaluation. In the three studies testing adult fleas, curative efficacies, 24 h after treatment, were 92.1%, 98.3% and 99.7%; preventive weekly efficacies, 24 h after weekly infestations, remained higher than 95.5% for at least one month. In the two studies testing immature stages, egg production and larval hatching was significantly reduced for at least one month. These studies provide robust evidence of efficacy of the novel formulation against experimental adult flea infestations and for the prevention of environmental contamination by immature flea stages, for at least one month.

Esafoxolaner, a purified enantiomer of afoxolaner with insecticidal and acaricidal properties, is combined with eprinomectin and praziquantel, nematodicidal and cestodicidal compounds, in NexGard®Combo, a novel topical endectoparasiticide formulation for cats. The efficacy of this formulation was assessed againstOtodectes cynotisin two laboratory studies conducted in South Africa and in the USA with local isolates, and in one field trial conducted in Europe. In each study, cats were randomly allocated to a placebo-treated control group and a novel formulation-treated group. In the laboratory studies, cats were treated at the minimum recommended dose; in the field trial, cats were treated at label dose. All included cats were diagnosed positive forO. cynotisprior to treatment by otoscopy. The main variable of efficacy was a comparison of the number of liveO. cynotiscollected in both ear canals of all cats in the treated and control groups, one month after treatment. Efficacy of the novel topical formulation exceeded 97% in the three studies. These studies demonstrated the high effectiveness of NexGard®Combo in cats for the treatment ofO. cynotisinfestations. No health abnormalities were attributed to the treatment in any of the studies.

Eprinomectin and praziquantel, nematodicide and cestodicide compounds, are both combined with the insecticide and acaricide compounds fipronil and (S)-methoprene in Frontline® Protect/Broadline®, or esafoxolaner in NexGard® Combo. These topical feline endectoparasiticide products were tested for efficacy against fleas and intestinal helminths in a field trial in Brazil. Flea- and/or helminth-infested domestic cats were treated twice at a monthly interval following label instructions: 160 cats with Frontline® Protect/Broadline® and 165 cats with NexGard® Combo. The flea and intestinal helminth infestations were evaluated using comb counts and copromicroscopy, respectively before first treatment for baseline value, then 9 and 30 days after each treatment for fleas, and 9 days after each treatment for helminths. Multiparasitism was very frequent at baseline, as amongst the 325 included cats, 295, 280, 86 and 93 cats were at least infested with Ctenocephalides fleas, Ancylostoma, Toxocara and Dipylidium caninum, respectively. Efficacies were calculated by comparing the geometric means at baseline and at post-treatment timepoints for each parasite genus/species. Inclusive of both products and of all evaluation timepoints, the Ctenocephalides, Ancylostoma, Toxocara and D. caninum efficacies were at least 98.3%, 99.8%, 99.8% and 96.3%, respectively. No adverse reactions were observed, except for a few instances of mild, transient, and self-resolving hypersalivation occurring on the day of treatment in both groups. This field trial demonstrated high-level efficacy of Frontline® Protect/Broadline® and NexGard® Combo against major parasites of cats in Brazil.

Background A multi-centre field trial was conducted to evaluate the efficacy of afoxolaner based chewables (NexGard® or NexGard Spectra®) for the treatment of generalised demodicosis caused by Demodex canis in dogs under field conditions in France, Italy and Poland. Methods Client-owned dogs, diagnosed positive for Demodex mites by pre-treatment skin scrapings and presenting clinical signs of generalised demodicosis were included. Dogs were orally treated with afoxolaner three times at monthly intervals. Of the 50 dogs enrolled, 48 completed the whole study. Efficacy of the treatments was assessed monthly by Demodex mite counts and physical examination with special regard to the severity and extension of skin lesions. Results Treatments were well tolerated in all dogs and resulted in a rapid reduction of mites, with all post-treatment mite counts significantly lower than baseline. The number of mites was reduced by 87.6%, 96.5% and 98.1% on Days 28, 56 and 84, respectively. In addition, the skin lesion severity and extent scores as well as the pruritus were all significantly lower at all post-treatment visits compared to the pre-treatment assessment. Conclusions This clinical field study demonstrated that monthly administrations of afoxolaner in NexGard® or NexGard Spectra®, offered a convenient and reliable solution for the treatment of canine generalised demodicosis.

NexGard® Combo, a novel topical endectoparasiticide product for cats, is a combination of esafoxolaner, eprinomectin and praziquantel. The safety of this novel combination administered to females during reproduction and lactation was evaluated per analysis of breeding parameters and adverse reactions observed on females and offspring. Females with successful breeding history were randomized to three groups, a placebo group and groups treated with the novel formulation at 1× or 3× multiples of the maximum exposure dose. Females were dosed at 28-day intervals, at least twice before mating, then during a period including mating, pregnancy, whelping and 56 days of lactation. In the placebo, 1× and 3× groups, 10, 9 and 10 females, respectively completed the study (nine, seven and nine females achieved pregnancy), and were dosed 7.1 times on average. Breeding parameters included success of mating, success of gestation, length of gestation, abortion rate, number of live, dead and stillborn kittens at birth, number of kittens with abnormalities, weight of kittens after birth and at weaning, growth of kittens, proportion of male and female kittens, and proportion of kittens born alive and weaned. No significant adverse reactions related to the novel combination were observed on females and on kittens; no significant and adverse effects on breeding parameters were observed.

Esafoxolaner is a purified enantiomer of afoxolaner with insecticidal and acaricidal properties. It is combined with eprinomectin and praziquantel in a novel topical endectoparasiticide formulation for cats. The efficacy of this novel formulation was evaluated in three Ixodes ricinus and two Ixodes scapularis experimental studies, with comparable designs. In each study, cats were randomly allocated, based on a pre-treatment tick infestation and count, to a placebo control group or a group treated with the minimum recommended dose of the novel formulation. Cats were infested two days before treatment and weekly thereafter. Immediate efficacy was evaluated 48 h after treatment; persistent efficacy was evaluated 48 h after new weekly infestations for at least one month after the treatment (in one of the studies, the first two weeks of persistent efficacy against I. ricinus were not tested). Efficacy was calculated at each timepoint by comparison of arithmetic means of live ticks found in the control and the treated groups. In the three studies targeting I. ricinus, immediate and persistent efficacies ranged between 91% and 100% for five weeks. In the two studies targeting I. scapularis, immediate and persistent efficacies ranged between 95% and 100%, and 98% and 100% for one month, respectively. These studies provide robust evidence of efficacy of the novel topical formulation of esafoxolaner, eprinomectin and praziquantel against experimental I. ricinus and I. scapularis infestations for at least one month in cats.Efficacité d’une nouvelle association topique d’esafoxolaner, d’éprinomectine et de praziquantel contre Ixodes ricinus et Ixodes scapularis chez le chat.L’esafoxolaner est un énantiomère purifié de l’afoxolaner aux propriétés insecticides et acaricides. Il est associé à l’éprinomectine et au praziquantel dans une nouvelle formulation d’endectoparasiticide topique pour chats. L’efficacité de cette nouvelle formulation a été évaluée dans trois études expérimentales sur Ixodes ricinus et deux sur Ixodes scapularis, avec des conceptions comparables. Dans chaque étude, les chats ont été répartis au hasard, sur la base d’une infestation et d’un nombre de tiques avant le traitement, dans un groupe témoin placebo ou dans un groupe traité avec la dose minimale recommandée de la nouvelle formulation. Les chats ont été infestés deux jours avant le traitement et une fois par semaine par la suite. L’efficacité immédiate a été évaluée 48 heures après le traitement et l’efficacité persistante a été évaluée 48 heures après les nouvelles infestations hebdomadaires pendant au moins un mois après le traitement (dans l’une des études, les deux premières semaines d’efficacité persistante contre I. ricinus n’ont pas été testées). L’efficacité a été calculée à chaque temps d’évaluation par comparaison des moyennes arithmétiques des tiques vivantes trouvées dans les groupes témoins et traités. Dans les trois études ciblant I. ricinus, les efficacités immédiates et persistantes variaient entre 91 % et 100 % pendant cinq semaines. Dans les deux études ciblant I. scapularis, les efficacités immédiates et persistantes variaient respectivement entre 95 % et 100 % et 98 % et 100 % pendant un mois. Ces études fournissent des preuves solides de l’efficacité de la nouvelle formulation topique d’esafoxolaner, d’éprinomectine et de praziquantel contre les infestations expérimentales par I. ricinus et I. scapularis pendant au moins un mois chez le chat.

NexGard® Combo, a novel topical endectoparasiticide formulation for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment of internal and external parasite infestations, including arthropods, nematodes and cestodes, was tested for efficacy against induced infections of Echinococcus multilocularis in cats, in two experimental studies. The two studies were performed in the United States with the same E. multilocularis isolate sourced locally. In each study, 20 cats were inoculated intra-gastrically with ~30,000 E. multilocularis protoscoleces three weeks before treatment, then ten cats were randomly allocated to a placebo control group or to the novel formulation treated group. Inoculated cats were treated topically once at the minimum recommended dose of the novel formulation, or with an identical volume of placebo. One week after treatment, cats were humanely euthanized for parasite recovery and count. The efficacy calculation was based on comparison of number of scoleces found in the control group and the novel formulation group. In the two control groups, E. multilocularis scoleces were found in five (range: 30–1025) and eight (range 2–345) cats, the geometric means inclusive of the ten cats per group were 8.9 and 28.8, respectively. In the two novel formulation-treated groups, none of the cats harbored any E. multilocularis scoleces, demonstrating 100% efficacy.

NexGard®Combo, a novel topical antiparasitic product for cats, combines the insecticide/acaricide esafoxolaner with the nematocide eprinomectin and cestodicide praziquantel. The efficacy of this combination product was evaluated against two common endoparasites of global occurrence in cats, the nematodeToxocara catiand the cestodeDipylidium caninum, in five controlled studies using naturally or experimentally infected cats with parasites of North American, South African or European origin. Cats evaluated in these studies harbored patent infection of the target parasite confirmed through a pre-treatment fecal examination. In each study, cats were allocated randomly to two groups of equal size (8 or 10 cats per group per study), one group treated with a placebo (mineral oil) and the other with NexGard®Combo. Both treatments were administered once as a spot-on at 0.12 mL per kg body weight to deliver the minimum label dosage (1.44 mg/kg esafoxolaner, 0.48 mg/kg eprinomectin, and 10.0 mg/kg praziquantel) to the NexGard®Combo-treated cats. To determine efficacy, geometric mean parasite counts seven to 12 days after treatment of placebo-treated (control) cats and NexGard®Combo-treated cats were compared. The efficacy of NexGard®Combo was 98.8% and 100% against adultT. catiin two studies; and 98.0%, 98.3% and 93.2% againstD. caninumin three studies.No adverse events related to treatment were observed throughout the studies. These studies demonstrate high efficacy against these major feline endoparasites and excellent acceptability of the novel topical antiparasitic combination of esafoxolaner, eprinomectin and praziquantel.

The insecticidal activity of oral afoxolaner (NexGard®) against stable flies Stomoxys calcitrans (Diptera: Muscidae) that had fed on dogs was evaluated in a blinded, randomised, and negative controlled efficacy study. The efficacy assessments were based on survival rates of fed flies after challenges to treated dogs. For a challenge, each dog was exposed to 50 unfed S. calcitrans for 30 minutes, after which time live fed flies were collected and incubated in an insectarium for viability assessment after 48, 72 and 96 hours. Fourteen dogs were randomly allocated to an untreated control group and an afoxolaner-treated group of seven dogs each. NexGard® was administered on Day 0 per label instructions to the treated group. All dogs were challenged on Days 1, 7, 14, 21 and 28. Efficacy was calculated by comparison of the proportion of incubated live fed flies for each individual after their related 30-min challenges in the control and treated groups after 48, 72 and 96 hours of incubation. A significant afoxolaner activity against S. calcitrans was demonstrated, with efficacy at 96 hours after blood-feeding ranging from 76.4 to 98.5% through Day 28.

Esafoxolaner is a purified afoxolaner enantiomer with insecticidal and acaricidal properties. It is combined with eprinomectin and praziquantel, nematodicidal and cestodicidal compounds, in a novel topical endectoparasiticide formulation for cats. This novel formulation was tested in four field studies, in the United States, Europe, Japan and Australia. In all studies, naturally flea-infested domestic cats were treated with the novel formulation at the label dose and conditions of use. The main objective, identical in the four studies, was to assess efficacy on fleas, based on comparison of mean number of fleas found on infested cats before and one month after treatment. Tolerance to the product was also evaluated in the four studies. Otherwise, the studies had some differences in their design and secondary objectives, for example testing for a reduction in flea infestation-related cutaneous signs, testing of one treatment or of three monthly treatments, and use of a positive control group. In the four studies, a total of 307 cats were treated with the novel formulation. The reduction of fleas one month after treatment was 97.7%, 98.8%, 100% and 99.7% in the United States, Europe, Japan and Australia, respectively. There were no significant health abnormalities attributed to treatment in any of the studies.Efficacité d’une nouvelle association topique d’esafoxolaner, d’éprinomectine et de praziquantel contre les puces chez les chats, dans des conditions de terrain.L’esafoxolaner est un énantiomère d’afoxolaner purifié aux propriétés insecticides et acaricides, et il est associé à l’éprinomectine et au praziquantel, des composés nématodicides et cestodicides, dans une nouvelle formulation d’endectoparasiticide topique pour chats. Cette nouvelle formulation a été testée dans quatre études sur le terrain, aux États-Unis, en Europe, au Japon et en Australie. Dans toutes les études, des chats domestiques naturellement infestés de puces ont été traités avec la nouvelle formulation à la dose et aux conditions d’utilisation indiquées sur l’étiquette. L’objectif principal, identique dans les quatre études, était d’évaluer l’efficacité contre les puces, sur la base de la comparaison du nombre moyen de puces trouvées sur des chats infestés avant et un mois après le traitement. La tolérance à l’application du produit a également été évaluée dans les quatre études. Sinon, les études présentaient des différences dans leur conception et leurs objectifs secondaires, par exemple test de réduction des signes cutanés liés à l’infestation par les puces, test d’un traitement ou de trois traitements mensuels, utilisation d’un groupe témoin positif. Dans les quatre études, un total de 307 chats ont été traités avec la nouvelle formulation. La réduction du nombre de puces un mois après le traitement était de 97,7 %, 98,8 %, 100 % et 99,7 % aux États-Unis, en Europe, au Japon et en Australie, respectivement. Aucune anomalie de santé significative n’a été attribuée au traitement dans aucune des études.

A fixed-combination chewable tablet incorporating afoxolaner plus milbemycin oxime (NexGard Spectra®, Merial) was tested in purpose-bred Beagle dogs for efficacy against adult Ancylostoma ceylanicum hookworms. Sixteen dogs were inoculated each by oral administration of approximately 500 infective larvae of A. ceylanicum. Seventeen days after inoculation, the dogs were weighed and allocated randomly to be treated with afoxolaner plus milbemycin oxime chewable tablets or to remain untreated. Commercial chewable tablets of different strength were combined to deliver doses as close as possible to the minimum effective dose of 2.5mg afoxolaner plus 0.5mg milbemycin oxime per kg body weight. Parasites were recovered and counted for determination of efficacy seven days after treatment. All eight dogs that had been left untreated were harboring adult A. ceylanicum (geometric mean, 317.8; range, 210-428) while only one and nine A. ceylanicum were recovered from two of the eight dogs treated with afoxolaner plus milbemycin oxime chewable tablets (geometric mean, 0.5; p

The efficacy of a novel topical combination of fipronil 8.3% (w/v), (S)-methoprene 10% (w/v), eprinomectin 0.4% (w/v) and praziquantel 8.3% (w/v) (BROADLINE(®)) was tested against adult and immature stages of Ctenocephalides felis fleas in six studies. For that purpose, fleas from different colonies from North America, Germany and South Africa were used to induce infestations in cats under laboratory conditions. In each study, between 12 and 16 cats were allocated randomly to 2 groups. Cats in Group 1 were not treated and served as controls. Cats in Group 2 were treated once on Day 0 with BROADLINE(®) at the minimum recommended dosage of 0.12 mg/kg body weight. In 4 studies, all animals were infested experimentally with unfed C. felis (100 ± 5) on Days 2 (or 1), 7, 14, 21, 28 and 35. Live fleas were counted 24h post-treatment or infestation. In 2 additional studies, animals were infested at the same frequency with gravid C. felis fleas (100 ± 5) that were fed previously on an untreated host. Forty-eight hours post-infestation, flea eggs were collected, counted and incubated for the evaluation of the reduction of emergence of adults. The combined curative efficacy against adult fleas at 24h after treatment was 94.3% and the combined preventive efficacy values remained greater than 95.9% at 24h after 5 subsequent weekly infestations. In addition, the product reduced dramatically the emergence of new adult fleas for at least 5 weeks (>98.1% for one month and 93.2% at 5 weeks after infestation), demonstrating its efficiency in preventing environmental contamination by immature stages.

Cats may be infected by heartworm, Dirofilaria immitis, through mosquito bites. They can develop severe heartworm disease when infective D. immitis larvae migrate and develop into adults in the pulmonary vasculature or other tissues. As there is no curative treatment for feline heartworm infection, the monthly administration of preventative treatment is recommended in endemic areas. Three controlled, blinded laboratory studies were conducted to evaluate the preventative efficacy of BROADLINE®, a novel combination of fipronil, (S)-methoprene, eprinomectin, and praziquantel against D. immitis in cats. In each study, 28 cats were inoculated with approximately 100 (studies 1 and 2) or 40 (study 3) infective third stage D. immitis larvae by subcutaneous injection, thirty days prior to treatment. The larvae were from recent field isolates from naturally infected dogs from three distinct geographic areas (two in the USA and one in Europe). In each study, the cats were allocated randomly to two study groups of 14 cats each. The control group remained untreated. On Day 0, each cat in the treated group received one topical application of the novel topical formulation, delivering the minimum intended dose of 0.5mg of eprinomectin per kilogram of body weight. At 6 months after infection, all cats were humanely euthanized and examined for adult D. immitis. Across all three studies, 28 (68%) of the 41 untreated cats harbored one or more heartworms, while 100% of the 42 treated cats remained free of heartworm infection, demonstrating the 100% preventive efficacy of BROADLINE® against D. immitis in cats. The treatment was well tolerated and no health abnormality was observed in any treated cat.

Five controlled, blinded and randomized studies were conducted to examine the efficacy of a single topical application of a combination of fipronil, (S)-methoprene, eprinomectin, and praziquantel (BROADLINE ® , Merial) against induced infestations with Ixodes ticks on cats. Three studies investigated the efficacy against Ixodes ricinus and two against Ixodes scapularis . In each study, purpose-bred cats were assigned at random to an untreated group or to a treated group. For the studies using I. ricinus , cats were infested with 50 female ticks and a similar number of males 2 days before treatment application, and weekly afterwards on between four and six occasions. For the studies using I. scapularis , cats were infested with a total of 50 ticks (approximately 25 females and 25 males) according to the same schedule as for I. ricinus . Tick counts for the evaluation of efficacy were performed 48 h after treatment and 48 h after the subsequent weekly infestations. Weekly attachment rates to untreated cats of at least 29% for I. ricinus and at least 30% for I. scapularis demonstrated consistently that the ticks were vigorous and that the attachment rates were adequate for efficacy evaluation. In the I. ricinus studies, an efficacy of at least 93% was demonstrated for up to 37 days after the treatment. In the I. scapularis studies, the efficacy level was at least 95% 30 days after the treatment. The product was well tolerated and caused no adverse reaction.

A novel topical combination product (BROADLINE(®), Merial) composed of fipronil, (S)-methoprene, eprinomectin and praziquantel was evaluated for safety and efficacy against nematode and cestode infections in domestic cats. The study comprised a multi-centre, positive control, blinded, field study, using a randomized block design based on order of presentation for allocation. In total 196 client-owned cats, confirmed as positive for naturally acquired infections of nematodes and/or cestodes by pre-treatment faecal examination, were studied in seven countries in Europe. Pre-treatment faecal examination revealed the presence of Toxocara, hookworm, Capillaria and/or spirurid nematode infections in 129, 73, 33 or 1 cat(s), respectively; infections with taeniid and Dipylidium cestodes were demonstrated in 39 and 17 cats, respectively. Cats were allocated randomly to one of two treatments in a ratio of 2, topical fipronil (8.3%, w/v), (S)-methoprene (10%, w/v), eprinomectin (0.4%, w/v) and praziquantel (8.3%, w/v) (BROADLINE(®), Merial; 130 cats); and 1, topical PROFENDER(®) Spot-On (Bayer; 66 cats) and treated once on Day 0. For evaluation of efficacy, two faecal samples were collected, one prior to treatment (Day -4 ± 4 days) and one at the end of the study (Day 14 ± 5 days). These were examined for fecal forms of nematode and cestode parasites. For evaluation of safety, cats were examined by a veterinarian before treatment and at the end of the study, and cat owners recorded the health status of their cats daily until the end of the study. For cats treated with Broadline(®), the efficacy was >99.9%, 100%, and 99.6% for Toxocara, hookworms, and Capillaria, respectively; and the efficacy was >99.9%, >99.9%, and 98.5%, respectively, for the cats treated with Profender(®) (p

Background Infection of dogs with the cardiopulmonary nematode Angiostrongylus vasorum may result in severe clinical disease therefore adequate prevention is necessary. A randomized, negative control, blinded study was conducted to evaluate the efficacy in the prevention of canine A. vasorum infection after monthly administrations of NexGard Spectra®, a novel chewable tablet formulation combining the insecticide and acaricide afoxolaner and the anthelmintic milbemycin oxime, in a multiple challenge (trickle infection) model. Methods Twenty beagle dogs were challenged orally with doses of approximately 32–43 third-stage larvae of A. vasorum once every other week on seven occasions (Study Days -7, 7, 21, 35, 49, 63 and 77). Ten dogs were administered NexGard Spectra® as close as possible to the minimum recommended dose of afoxolaner and milbemycin oxime, i.e. 2.5 mg/kg body weight and 0.5 mg/kg body weight, respectively, four times at monthly intervals (Study Days 0, 28, 56 and 84) while the remaining ten dogs served as untreated controls. For parasite recovery and count, dogs were euthanized humanely and necropsied six to eight days following the last treatment (Study Days 90–92). Beginning six weeks after first inoculation, faeces were collected on a bi-weekly basis and examined for first-stage larvae of A. vasorum. Results Untreated dogs harboured 39–95 adult A. vasorum (geometric mean, 66.4), while zero to 24 adult A. vasorum were recovered from the treated dogs (geometric mean, 3.4; P

The acaricidal efficacy against Dermacentor reticulatus in dogs of the commercial topical combinations fipronil/(S)-methoprene (FRONTLINE Combo® spot-on dog), imidacloprid/permethrin (Advantix®) and metaflumizone/amitraz (ProMeris Duo®) was evaluated and compared. Three treatment groups and one untreated control group of six adult Beagle dogs each were randomly formed. Each treatment was administered topically once on Day-0, according to the recommended label dose and instructions for use. All dogs were infested weekly with approximately 50 adult unfed D. reticulatus over a period of seven weeks. Ticks were removed and counted approximately 48 hours after each infestation. The percent reduction in numbers of ticks for fipronil/(S)-methoprene was ≥ 97 % compared to untreated controls for all seven weekly infestations. The percent reductions for imidacloprid/permethrin and metaflumizone/amitraz were satisfactory initially but fell and stayed below 90 % after three weeks. From the third week onwards, fipronil/(S)-methoprene treated dogs had significantly fewer ticks than imidacloprid/ permethrin or metaflumizone/amitraz treated dogs (p < 0.05).

Although foxes are the main reservoir of Echinococcus multilocularis, it is recognized that dogs and cats also may become infected. In cats the infection and egg production rates are usually low. Nevertheless, cats are a potential source of transmission of E. multilocularis. Due to the high human medical significance of E. multilocularis infection, it is important in endemic areas that owned cats are dewormed regularly. This paper presents the efficacy results of a new topical formulation, Broadline® (Merial) tested against E. multilocularis infection in cats. Two blinded laboratory studies were conducted to evaluate this novel topical combination of fipronil, (S)-methoprene, eprinomectin, and praziquantel against E. multilocularis. In each study, purpose-bred cats were assigned randomly to two treatment groups of 10 cats each: one untreated control group and one group treated at the minimum therapeutic dose of 0.12mL/kg bodyweight to deliver 10mg fipronil, 12mg (S)-methoprene, 0.5mg eprinomectin and 10mg praziquantel/kg bodyweight. The cats were inoculated orally with E. multilocularis protoscolices, 22 or 23 days before treatment. Based on necropsy and intestinal worm count, 8 or 11 days after treatment, the two studies confirmed 100% efficacy of Broadline® against adult E. multilocularis.