Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats
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 s...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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EDP Sciences
2021-01-01
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| Series: | Parasite |
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| Online Access: | https://www.parasite-journal.org/articles/parasite/full_html/2021/01/parasite200150/parasite200150.html |
| _version_ | 1797423378023317504 |
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| author | Gupta Aradhana Baker Christine Wang Hailun Targa Norba Pfefferkorn Anthony Tielemans Eric |
| author_facet | Gupta Aradhana Baker Christine Wang Hailun Targa Norba Pfefferkorn Anthony Tielemans Eric |
| author_sort | Gupta Aradhana |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T07:47:04Z |
| format | Article |
| id | doaj.art-c1d056c841c44c788a3ba1a588cca7cf |
| institution | Directory Open Access Journal |
| issn | 1776-1042 |
| language | English |
| last_indexed | 2024-03-09T07:47:04Z |
| publishDate | 2021-01-01 |
| publisher | EDP Sciences |
| record_format | Article |
| series | Parasite |
| spelling | doaj.art-c1d056c841c44c788a3ba1a588cca7cf2023-12-03T03:16:50ZengEDP SciencesParasite1776-10422021-01-01281810.1051/parasite/2021015parasite200150Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for catsGupta Aradhana0Baker Christine1Wang Hailun2Targa Norba3Pfefferkorn Anthony4Tielemans Eric5https://orcid.org/0000-0003-4798-3246Boehringer-Ingelheim Animal HealthBoehringer-Ingelheim Animal HealthBoehringer-Ingelheim Animal HealthBoehringer-Ingelheim Animal HealthBoehringer-Ingelheim Animal HealthBoehringer-Ingelheim Animal HealthThe 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.https://www.parasite-journal.org/articles/parasite/full_html/2021/01/parasite200150/parasite200150.htmlcatesafoxolanereprinomectinpraziquantelsafetytopical |
| spellingShingle | Gupta Aradhana Baker Christine Wang Hailun Targa Norba Pfefferkorn Anthony Tielemans Eric Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats Parasite cat esafoxolaner eprinomectin praziquantel safety topical |
| title | Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats |
| title_full | Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats |
| title_fullStr | Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats |
| title_full_unstemmed | Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats |
| title_short | Target animal safety evaluation of a novel topical combination of esafoxolaner, eprinomectin and praziquantel for cats |
| title_sort | target animal safety evaluation of a novel topical combination of esafoxolaner eprinomectin and praziquantel for cats |
| topic | cat esafoxolaner eprinomectin praziquantel safety topical |
| url | https://www.parasite-journal.org/articles/parasite/full_html/2021/01/parasite200150/parasite200150.html |
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