Abstract
BackgroundRobenacoxib is a non-steroidal anti-inflammatory drug available for canine and feline use for the control of pain and inflammation marketed as Onsior™. The aim of this target animal safety study was to evaluate the 6-month safety profile of oral robenacoxib administration. It was a randomized, negative-controlled, parallel group study. Thirty-two healthy, young, experimentally naïve, purebred Beagle dogs were administered 0 (sham control, Group 1), 2, 6, and 10 mg/kg robenacoxib (corresponding to the upper end of the dosage range [1X, Group 2] and multiples thereof [3X and 5X, Group 3 and 4]), orally once daily for 6 months. Assessment of safety included general health and clinical observations, physical, neurological, ophthalmological and electrocardiographic examinations, gross and histopathological examinations and clinical pathology evaluations. Blood samples were collected for toxicokinetic assessment of robenacoxib.ResultsNo serious adverse events were reported. When compared with control, no treatment effect was observed for body weight, feed or water consumption, clinical pathology, urinalysis and fecal examination parameters. There were no treatment-related changes in stifle joint tissues and microscopic/histopathology examinations of all tissues/organs were normal. Salivation and soft feces were noted in all groups but observed more frequently in the treated groups as compared with control. On Day 178, increased buccal mucosal bleeding times were observed in two treated animals (Group 3 and 4) and one dog in Group 4 displayed a retinal change. Decreased hopping and conscious proprioception was noted in four treated dogs. One dog in Group 2 had ventricular premature complexes. Post-mortem changes included mild, red foci on the cecum in one dog (Group 3) and minimal duodenal discoloration in one dog (Group 4), with no corresponding histological findings in either dog. Ovarian weights were decreased in females from Group 3 and 4 with no gross or histological changes in the ovaries. Blood concentrations of robenacoxib confirmed systemic exposure of treated dogs. Exposure increased with increasing doses and there were no accumulation of robenacoxib in blood.ConclusionsRobenacoxib was well tolerated at doses from 2 to 10 mg/kg/day and this 6-month study supports the safe use of Onsior™ (robenacoxib) tablets in dogs for the intended dosing regimen.
Highlights
Robenacoxib is a non-steroidal anti-inflammatory drug available for canine and feline use for the control of pain and inflammation marketed as OnsiorTM
The non-steroidal anti-inflammatory (NSAID) drug robenacoxib has been developed for veterinary use in cats and dogs [1, 2]
It is highly selective for inhibition of the cyclooxygenase (COX)-2 [3,4,5] with a fast onset of action in cats [6] and dogs [7] and an improved safety profile as compared with non-selective Non-steroidal anti-inflammatory drug (NSAID) [8,9,10]
Summary
The aim of this target animal safety study was to evaluate the 6-month safety profile of oral robenacoxib administration. The non-steroidal anti-inflammatory (NSAID) drug robenacoxib has been developed for veterinary use in cats and dogs [1, 2] It is highly selective for inhibition of the cyclooxygenase (COX)-2 [3,4,5] with a fast onset of action in cats [6] and dogs [7] and an improved safety profile as compared with non-selective NSAIDs [8,9,10]. These studies were conducted with a prototype formulation of robenacoxib which necessitated a target animal safety study to be conducted with the final commercial product in order to obtain global marketing authorizations, as outlined in the guideline for evaluating the target animal safety of new veterinary products (VICH Guideline 43) [13]
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