Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats

Special Issue – NexGard^® Combo (esafoxolaner, eprinomectin, praziquantel): A new endectocide spot-on formulation for cats. Invited Editor: Frédéric Beugnet

Open Access

Table 1

Study designs.

Target animal safety studies	Preliminary margin-of-safety topical (Study #1)	Regulatory margin-of-safety topical (Study #2)	Regulatory oral tolerance (Study #3)
Investigated product(s)	Esafoxolaner 1.2% w/v, eprinomectin 0.4% w/v, praziquantel 8.3% w/v	NexGard^® Combo:
Investigated product(s)	Esafoxolaner 5.5% w/v	esafoxolaner 1.2% w/v, eprinomectin 0.4% w/v, praziquantel 8.3% w/v
Study groups (number of male and female cats)	One control group (no treatment) (1 M, 1 F)	One control group (mineral oil) (4 M, 4 F)	One control group (sterile water) (4 M, 4 F)
	Three treatment groups:	Three treatment groups:	One treatment group:
	3× (3 M, 3 F)	1× NexGard^® Combo (4 M, 4 F)	1× NexGard^® Combo (4 M, 4 F)
	5× (3M, 4F)	3× NexGard^® Combo (4M, 4F)
	Esafoxolaner 103.1 mg/kg (1.875 mL/kg) (4M, 2F)	5× NexGard^® Combo (4M, 4F)
Number and frequency of treatments	3× and 5× groups: Four topical applications at 2-week intervals (i.e., Days 0, 14, 28 and 42)	Control and all treatment groups: Six topical applications at 4 week intervals (i.e., Days 0, 28, 56, 84, 112 and 140)	Control and the treatment group: single oral administration on Day 0
Number and frequency of treatments	Esafoxolaner group: Two topical applications at 4-week intervals (i.e., Days 0 and 28)
Study variables	Clinical reactions, bodyweight, clinical pathology, anatomical pathology	Clinical reactions, bodyweight, food and water consumption, clinical pathology, anatomical pathology	Clinical reactions, bodyweight, food and water consumption, clinical pathology
Age of cats at study start	8–10 weeks	8–9 weeks	7–9 weeks

1× Group: 4.5 mg/kg esafoxolaner, 1.5 mg/kg eprinomectin, 31.1 mg/kg praziquantel (maximum exposure dose: 0.375 mL/kg).

3× Group: 13.5 mg/kg esafoxolaner, 4.5 mg/kg eprinomectin, 93.4 mg/kg praziquantel (3X maximum exposure dose: 1.125 mL/kg).

5× Group: 22.5 mg/kg of esafoxolaner, 7.5 mg/kg eprinomectin, 155.6 mg/kg praziquantel (5X maximum exposure dose: 1.875 mL/kg).

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