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Three controlled, blinded and randomised multicentre field studies evaluated the efficacy and safety of a new formulation containing emodepside plus toltrazuril (Procox® suspension for dogs) against naturally acquired parasite infections in dogs. In two studies dogs positive for gastrointestinal nematodes and/or Isospora spp. were treated with emodepside/toltrazuril suspension (at least 0.45 mg emodepside plus 9 mg toltrazuril per kg body weight) or a reference product containing either milbemycin oxime plus praziquantel (Milbemax®) or sulfadimethoxine (Kokzidiol SD®) at recommended dose rates. The third study investigated efficacy against prepatent natural Isospora spp. infections in comparison to an untreated control group by enrolling Isospora- negative dogs that were at risk to develop a patent infection during the study.No suspected adverse drug reactions were observed in any of the 403 dogs enrolled in the three studies including 234 dogs treated with emodepside/toltrazuril suspension. In dogs treated with emodepside/toltrazuril suspension against nematode infection faecal egg counts were reduced by 100 % (reference product: 99.7 %). Similarly, in the dogs that had been treated against patent Isospora spp. infection, faecal oocyst counts were reduced by 100 % (reference product: 99.0 %). In both studies, statistical analysis demonstrated non-inferiority and even superiority to the reference products (p ≤ 0.009). Dogs treated with emodepside/toltrazuril suspension during suspected prepatent Isospora spp. infection had 98.7 % lower faecal oocyst counts after treatment compared to untreated dogs (p < 0.0001).The studies demonstrated that emodepside/toltrazuril suspension is safe and highly efficacious against nematodes and Isospora spp. under field conditions.

Two exploratory studies were performed to determine the optimum therapeutic dose of Procox(®) for the removal of experimental infection with mature adult Toxocara (T.) cati and Ancylostoma (A.) tubaeforme in kittens. Procox(®) is a new oral suspension containing a combination of the nematocidal and coccidiocidal active principles emodepside (0.1 %) and toltrazuril (2 %).In the first study, 18 eight-weeks-old kittens were inoculated with 450 L3 larvae of T. cati. 56 days after infection, the kittens were allocated to three treatment groups and were treated with 0.5 mg emodepside/kg body weight (group 1), 0.25 mg emodepside/kg body weight (group 2) and 0.1 mg emodepside/kg body weight (group 3), respectively. In the second study, 10 eight-weeks-old kittens were inoculated with 350 L3 larvae of A. tubaeforme. Four weeks after infection, the kittens were allocated to two treatment groups and were treated with 0.1 mg emodepside/kg body weight (group 1) or 0.25 mg emodepside/kg body weight (group 2). In both studies, all kittens received a reference treatment with Drontal(®) (230 mg pyrantel embonate and 20 mg praziquantel per tablet) at the recommended dose of one tablet/4 kg body weight 5 days after treatment with Procox(®). Anthelmintic efficacy was calculated by reduction in worm numbers expelled with the faeces following treatment with Procox(®) as compared with faecal worm numbers after reference treatment with Drontal(®), by thus avoiding necropsy of the animals.In the T. cati study, emodepside was at 99.9 %, 100 % and 96.5 % effective at a dosage of 0.5 mg, 0.25 mg and 0.1 mg per kg body weight, respectively. Against A. tubaeforme emodepside was at 95.7 % and 100 % effective at a dosage of 0.1 mg and 0.25 mg per kg body weight. No adverse events were seen during either study.It can be concluded that Procox(®) is efficacious for the control of mature adult T. cati and A. tubaeforme infections in cats at a single-dose rate of 0.25 mg emodepside/kg body weight.

Three randomised, blinded and placebo-controlled laboratory studies were conducted to evaluate the efficacy of emodepside plus toltrazuril suspension (Procox(®) suspension for dogs) against Isospora canis and Isospora ohioensis-complex. Unweaned puppies were experimentally infected with sporulated oocysts of I. canis and/or I. ohioensis-complex. In each study, one group was treated during prepatency (2 or 4 days post infection) while dogs in the second group were treated individually after the onset of oocyst excretion of the respective coccidia species. The dogs were treated with the minimum therapeutic dose of 0.45 mg emodepside and 9 mg toltrazuril per kg body weight. Daily faecal oocyst counts from both groups were compared to placebotreated control groups to determine efficacy.Dogs treated during prepatent I. canis or I. ohioensis-complex infection showed significantly lower oocyst counts for up to 12 days compared to the control group. Oocyst counts were reduced by 90.2 - 100 % while the control groups continued to exhibit an adequate infection, except for one study where efficacy against prepatent I. canis infection faded 13 days after treatment. Following treatment of patent I. canis or I. ohioensis-complex infections, significantly lowered oocyst counts were observed for up to 9 days compared to the control group. Faecal oocyst counts were reduced by 91.5 - 100 %. In all three studies the number of days with diarrhoea was significantly lower when dogs were treated during prepatent Isospora spp. infection compared to the control groups. No adverse drug reactions were observed during the studies. In conclusion, the studies demonstrated that emodepside plus toltrazuril suspension is an efficient coccidiocide for dogs.

The efficacy of emodepside plus toltrazuril (Procox® oral suspension for dogs) against different species of gastrointestinal nematodes (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala) was evaluated in nine randomised,blinded and placebo-controlled laboratory studies in naturally or experimentally infected dogs. The product was used at the proposed minimum dose of 0.45 mg emodepside and 9 mg toltrazuril per kg body weight. Efficacy was calculated based on worm counts after necropsy. Worm burdens in the control dogs ranged between 0 and 409 worms of the respective stage for T. canis and between 4 and 655 worms for hookworms. The studies demonstrated 100 % efficacy of emodepside/toltrazuril suspension against mature adult, ≥ 94.7 %efficacy against immature adult and 99.3 % efficacy against the L4 larval stage of T. canis. The efficacy against mature adult A. caninum was ≥ 99.5 % and the efficacy against mature adult U. stenocephala was 100 %. All differences between treatment and control groups were statistically significant and no gender effect was found. It can be concluded that the emodepside/toltrazuril suspension represents a safe and highly effective product in dogs with nematode (T. canis, hookworms) infection.

This paper reports the efficacy of a novel flavoured tablet formulation of emodepside plus praziquantel (Profender tablets for dogs) against mature and immature adult hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs. The tablets were used at the minimum recommended dose of 1 mg emodepside and 5 mg praziquantel per kg body weight. Four randomised, blinded and controlled laboratory studies demonstrated >95% efficacy against mature and immature adult stages of U. stenocephala and four randomised, blinded and controlled laboratory studies demonstrated >98% efficacy against mature and immature adult stages of A. caninum. No side effects of the treatment were observed. It is concluded that the emodepside plus praziquantel tablet is an effective and safe treatment against mature and immature hookworms.

This laboratory study compared the efficacy of two treatment regimens using an imidacloprid (10%)/moxidectin (2.5%) topical formulation (Advocate, Bayer) on dogs with generalised demodicosis. Sixteen dogs were randomly allocated to two equal groups. One group was treated at 28-day intervals for 12 weeks and the second group at weekly intervals for 15 weeks. Mite numbers were estimated and demodectic lesions were evaluated on each dog before treatment and at approximately 28-day intervals thereafter. Consistently greater reduction in mite numbers was recorded for the weekly treatment regimen. Dogs treated at weekly intervals exhibited markedly fewer clinical signs and greater hair regrowth and weight gain than those treated at 28-day intervals. To assess the safety of a weekly treatment interval in dogs, a study was done in which the investigational compound was administered at weekly intervals at five times the recommended dose for a period of 16 consecutive weeks. Apart from transient erythema at the site of administration in one dog and scaliness of the skin in another, no clinical signs of toxicity could be observed. Assessment of 27 blood parameters indicated that only basophils were outside the reference values on days +13 and +69, during the safety trial period.

The efficacy of a novel flavoured tablet formulation of emodepside plus praziquantel (Profender tablets for dogs) against intestinal cestodes was investigated in four randomised, blinded placebo-controlled dose confirmation studies in dogs experimentally infected with Echinococcus granulosus or E. multilocularis and in dogs naturally infected with Dipylidium caninum or Taenia spp. The tablets were used at the minimum recommended dose of 1 mg emodepside and 5 mg praziquantel per kg body weight. The studies demonstrated 100% efficacy against mature and immature E. granulosus and E. multilocularis and mature Taenia spp. and D. caninum. Additionally, one of the studies demonstrated non-interference of emodepside with the efficacy of praziquantel against D. caninum. No side effects of the treatment were observed. It is concluded that emodepside plus praziquantel tablets are safe and effective against mature and immature stages of E. granulosus and E. multilocularis and mature stages of Taenia spp. and D. caninum.

A controlled, blinded and randomised multicentre field study evaluated the efficacy and safety of a new anthelmintic tablet formulation containing emodepside plus praziquantel (Profender tablets for dogs) in the treatment of gastrointestinal nematode and cestode infections in dogs in France, Germany, Portugal and Slovakia. Dogs positive for nematodes and/or cestodes (demonstrated by faecal egg counts and/or the presence of proglottids) were treated with emodepside plus praziquantel tablets (n = 239) or the reference product containing milbemycin oxime and praziquantel (Milbemax [n = 115]) at the recommended dose rate. Two faecal samples collected between 7 and 13 days after treatment were evaluated for proglottids, nematode and cestode eggs. No suspected adverse drug reactions were observed in the study. The following parasite species were identified: Trichuris vulpis, Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum, Dipylidium caninum, Taeniidae and Mesocestoides spp. Geometric mean nematode egg counts in dogs treated with emodepside plus praziquantel tablets were reduced by 99.9 % compared with a reduction of 99.6 % for the reference product. Statistical analysis demonstrated noninferiority of investigational versus reference product (p = 0.0342). None of the dogs treated with emodepside plus praziquantel or reference product remained positive for cestodes after treatment. The study demonstrated that emodepside plus praziquantel tablets are safe and highly efficacious against a broad spectrum of nematodes and cestodes under field conditions.

The efficacy of emodepside plus praziquantel tablets (Profender tablets for dogs) against mature adult, immature adult and larval stages of Toxocara canis and Toxascaris leonina was evaluated in ten randomised, blinded and placebo-controlled dose confirmation studies in naturally or experimentally infected dogs. The tablets were used at the proposed minimum dose of 1 mg emodepside and 5 mg praziquantel per kg body weight. Efficacy was calculated based on worm counts after necropsy. Five studies demonstrated >99% efficacy against mature adult, >92% efficacy against immature adult, >98% efficacy against L4 and >94% efficacy against L3 larval stages of T. canis. Another five studies demonstrated >99% efficacy against mature and immature adult and >95% efficacy against L4 larval stages of T. leonina. No side effects of the treatment were observed. Emodepside plus praziquantel tablets thus provide a comprehensive new treatment option for ascarid infections in the dog.

This paper reports on the efficacy of a novel flavoured tablet formulation of emodepside plus praziquantel (Profender tablets for dogs) against mature and immature adult whipworms (Trichuris vulpis) at the proposed minimum dose of 1 mg emodepside and 5 mg praziquantel per kg body weight in dogs. Three randomised, blinded and controlled laboratory studies with naturally or experimentally infected dogs were performed. The first study was conducted as a dose determination study in experimentally infected dogs using three different dose levels, i.e., 0.5x, 1x and 2x the minimum therapeutic dose. Two further studies confirmed the efficacy of emodepside plus praziquantel tablets against mature and immature adult T. vulpis at the recommended minimum dose. In all three studies, the efficacy against mature and immature adult T. vulpis was >99%. No side effects of the treatment were observed. It is concluded that the emodepside plus praziquantel tablet is an effective and safe treatment against mature and immature adult stages of T. vulpis in dogs.

Two controlled, blinded and randomized multi-site clinical field studies evaluated the efficacy and safety of emodepside/praziquantel spot-on in the treatment of gastrointestinal nematode and cestode infections in cats. In a study conducted in Europe, faecal egg count reductions of >98% for all nematode eggs and eggs of Toxocara cati, respectively, were observed in cats treated with emodepside/praziquantel spot-on (Profender, Bayer AG, Leverkusen, Germany). For a positive-control product containing selamectin (Stronghold) reductions of >95% were observed. A 100% reduction of faecal eggs and proglottids was observed in cats treated with emodepside/praziquantel spot-on that were infected with cestodes. In a study conducted in North America, cats were treated with either emodepside/praziquantel spot-on plus a placebo tablet or a combination of two control products containing, respectively, selamectin (Revolution) and epsiprantel (Cestex). Faecal egg count reduction for eggs of T. cati was >99% for both treatments. For faecal eggs and proglottids of Dipylidium caninum reductions of >99 and >97% were recorded for cats treated with emodepside/praziquantel spot-on and the control group, respectively. No adverse reactions were observed in the European study, and only mild ones of short duration in a few cats from both treatment groups of the North American study. The two studies demonstrated that emodepside/praziquantel spot-on is highly efficacious and safe under field conditions.

This paper reports the efficacy of emodepside/praziquantel spot-on (Profender), Bayer AG, Leverkusen, Germany), a novel broad-spectrum anthelmintic for dermal application, against L4 larvae and immature adult and adult stages of Ancylostoma tubaeforme in cats. The formulation contains 2.14% (w/w) emodepside and 8.58% (w/v) praziquantel, with emodepside being active against gastrointestinal nematodes and praziquantel against cestodes. Five randomized, blinded and controlled laboratory studies demonstrated 100% efficacy of emodepside/praziquantel spot-on against mature A. tubaeforme and an efficacy of >95% and >97%, respectively, against L4 larvae and immature adults (based on worm counts after necropsy) at approximately the minimum proposed dose rate in cats of 3.0 mg emodepside and 12.0 mg praziquantel/kg body weight. No adverse reactions to the treatment were observed. It is concluded that emodepside/praziquantel spot-on is an effective and safe treatment against infections with mature and immature A. tubaeforme. Emodepside/praziquantel spot-on will considerably facilitate the treatment of cats against nematodes and cestodes compared with orally administered preparations.