Target animal safety study of meloxicam administered via transmucosal oral spray (Promist(®) technology) for 6 months in dogs.

This study evaluated the safety of meloxicam administered via transmucosal oral spray (TMOS) at 1, 2, 3 and 5 times the maximum proposed dose for 6 months in dogs. After baseline assessments, 40 Beagles (20 M, 20 F) were randomized to gender-balanced groups administered either water or meloxicam TMOS at 1, 2, 3 and 5 times the maximum proposed dose once daily for 26 weeks. Dogs were subjected to daily food consumption measurements and clinical and dose site observations. Periodic evaluations were made of body weight, physical examination, clinical pathology, urinalysis, buccal mucosal bleeding time (BMBT) and gastroduodenal endoscopy. At study completion, all dogs were subjected to gross necropsy. Histopathology was performed on tissues from dogs in groups 0X and 5X and from selected tissues in other dose groups. Clinical signs of previously reported NSAID-associated gastrointestinal upset were noted with higher frequency in meloxicam-dosed animals than in controls. Despite the presence of statistically significant effects on some clinicopathological variables, no toxicologically relevant dose-associated effects were determined on these or on food consumption, dose site observations, body weight, physical examination, urinalysis, BMBT, endoscopic examination or gross and histopathological examination of necropsy tissues.