Field study evaluating the efficacy of a combination formulation of fluralaner with moxidectin and pyrantel (BRAVECTO® TriUNO) against canine intestinal nematode infections

Background There is a demand for broad-spectrum products effective against internal and external parasites to simplify dog-owner compliance with veterinary parasiticide treatment recommendations. A field study investigated the safety and efficacy of a broad-spectrum formulation of fluralaner, moxidectin, and pyrantel pamoate compared with a licensed afoxolaner–milbemycin oxime combination product in treating canine intestinal nematode infections in client-owned dogs at multiple sites in Europe. Methods Dogs with positive pre-treatment fecal egg counts (FEC) were randomized to treatment on day 0 with the investigative veterinary product (IVP), at dose rates of: IVP, fluralaner 10–20 mg/kg, moxidectin 0.025–0.050 mg/kg, pyrantel 5–10 mg/kg ( n = 172); or a control product (CP), afoxolaner 2.5–5.2 mg/kg, milbemycin oxime 0.5–1.0 mg/kg ( n = 86). On day 14, FEC were completed on all study dogs. Efficacy against any intestinal nematode species was claimed if the FEC reduction in ≥ 10 dogs initially positive for that species was ≥ 90%, and if the geometric mean difference between pre- and post-treatment FEC was statistically significant ( P ≤ 0.05). Results Study dogs were enrolled at veterinary clinics in Albania ( n = 60), Bulgaria ( n = 111), Greece ( n = 27), and Italy ( n = 60). Where a sufficient number of infected dogs allowed for statistical comparison, geometric mean FEC reductions on day 14 versus day 0 in the IVP group were significant ( P < 0.0001) for hookworms, Toxocara canis , Toxascaris leonina, Trichuris vulpis , and capillarid-type eggs. On the basis of geometric mean reductions in FEC relative to day 0, the efficacy of the IVP exceeded 99% against all intestinal nematode parasites, and FEC reductions in the CP exceeded 98%. The percentage of nematode-free dogs in the IVP group was statistically noninferior ( P < 0.0001) to the CP group and even statistically superior at the α = 0.025 level of significance (one-sided). There were no treatment-related adverse events. Conclusions In client-owned dogs, the combination of fluralaner–moxidectin–pyrantel is safe and effective for the treatment of intestinal infections with hookworms, ascarids, including T. canis , and whipworms. On the basis of the complete elimination of parasite ova from the feces evaluated in this study, this fluralaner–moxidectin–pyrantel combination demonstrated to be significantly superior ( P < 0.025) to an afoxolaner–milbemycin combination in the treatment of canine intestinal nematode infections.