Onsior Tablets for Dogs: Effectiveness and Safety
When administered postoperatively after soft-tissue surgery, Onsior Tablets for Dogs have been shown to be effective and well-tolerated for up to a maximum of 3 days.
A randomized, blinded, placebo-controlled pivotal field study to evaluate the effectiveness and safety of robenacoxib (tablets) when administered at a dose of 2 mg/kg once daily for 3 days for the control of postoperative pain and inflammation associated with soft-tissue surgery in dogs.
239 (143 females and 96 males) dogs of various breeds between 6 months and 14 years of age, weighing between 2.7 and 55 kg.
Dogs were randomized into two treatment groups in a 1:1 ratio, and received whole Onsior Tablets for Dogs or vehicle control tablets orally once daily for 3 days. Onsior Tablets for Dogs were dosed at 2 mg/kg (0.91 mg/lb).
All dogs received perioperative fluids and butorphanol as a preanesthetic medication.
All dogs received the first treatment approximately 45 minutes prior to surgery, and the two subsequent daily doses approximately 24 hours and 48 hours later.
Pain was evaluated using the short form of the Glasgow Composite Measuring Pain Scale (CMPS-SF). The following six CMPS-SF categories were assessed as secondary variables along with the total CMPS-SF score:
- Attention to wound area
- Response to touch
- Posture and activity
Dogs that received rescue pain medication, had a CMPS-SF score >6, or were removed due to adverse events were considered treatment failures. The primary effectiveness variable was treatment success or failure.
A statistically significant difference (p=0.0188) in the proportion of treatment successes in the Onsior Tablets for Dogs group compared to the control group was observed. 76.72% (robenacoxib) vs 64.35% (vehicle control). 27/116 dogs in the robenacoxib group and 41/115 in the control group were considered treatment failures, respectively.
For the individual variables, the analysis showed an overall significant post-treatment improvement (i.e., lower scores/less pain) in Response to Touch and Posture/Activity.
The most commonly reported adverse reactions in dogs treated with Onsior Tablets for Dogs were diarrhea/soft stools, vomiting and decreased appetite.
Adverse Reactions in the soft-tissue surgery field study
Onsior (robenacoxib) tablets N=120
Control (vehicle tablets minus robenacoxib) N=120
*Dogs may have experienced more than one type or occurrence of an event during the study.
Administration of Onsior Tablets for Dogs at a dose of 2 mg/kg (0.91 mg/lb) once daily for up to 3 days, with the first dose administered approximately 45 minutes prior to surgery, was effective and well-tolerated for the control of postoperative pain and inflammation with soft-tissue surgery in dogs.