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

Abstract 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. Graphical Abstract