Effectiveness and Safety

Safe and effective postsurgical soft-tissue pain management

With demonstrated safety and efficacy for use up to a maximum of 3 days, Onsior® (robenacoxib) should be top of mind for your spay/neuter patients.1

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.

Field Effectiveness and Safety Study

Study Objective
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.
Study Animals
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.
Treatment Groups
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).
Surgical Preparation
All dogs received perioperative fluids and butorphanol as a preanesthetic medication.
Drug Administration
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 Assessments
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:
  1. Vocalization
  2. Attention to wound area
  3. Mobility
  4. Response to touch
  5. Demeanor
  6. Posture and activity
Statistical Methods
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.
Results
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.
Adverse Reactions
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

Adverse Reaction*

Onsior (robenacoxib) tablets N=120

Control (vehicle tablets minus robenacoxib) N=120

Diarrhea
6
3
Vomiting
6
4
Decreased appetite
3
0
Weight loss
1
0
Hypotension
1
0

*Dogs may have experienced more than one type or occurrence of an event during the study.

Study Conclusion
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.

Onsior injection: Effectiveness and Safety

Field Effectiveness and Safety Study

Study Objective
A masked, placebo-controlled, multi-site field study was conducted to evaluate the effectiveness of Onsior injection when administered at a dose of 2 mg/kg (subcutaneous) once daily for 3 days for the control of postoperative pain and inflammation associated with soft-tissue surgery in dogs.
Study Animals
317 client-owned dogs of various breeds presenting for soft-tissue surgery.
Treatment Groups
Dogs were randomized into two treatment groups, receiving either Onsior injection or placebo once daily for 3 days.
Drug Administration
The drug or the placebo was administered approximately 45 minutes prior to surgery, along with preanesthetic medications, and continued once daily for two additional treatments.
Pain Assessments
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:
  1. Vocalization
  2. Attention to wound area
  3. Mobility
  4. Response to touch
  5. Demeanor
  6. Posture and activity
Statistical Methods
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.
Results
A statistically significant difference (p=0.0055) in the proportion of treatment successes in the Onsior injection treatment group compared to the control group was observed. 73.7% (robenacoxib) vs. 58.1% vehicle control) 43/151 dogs in the robenacoxib group and 67/152 dogs in the control group were considered treatment failures, respectively.

Statistically significant differences in reductions in Response to Touch scores (p=0.0013) and Posture/Activity (p=0.0466) were observed in the Onsior injection group relative to the placebo group.
Adverse Reactions
The most commonly reported adverse reactions in dogs treated with Onsior injection were pain on injection diarrhea, and vomiting.

Adverse Reactions in the soft-tissue surgery field study

Adverse Reaction*

Onsior (robenacoxib) injection N=159

Placebo (0.9% NaCl)
N=158

Pain on injection**
18
8
Diarrhea
15
8
Vomiting
10
6
Bradycardia
6
1
Decreased appetite
5
2
Hypotension
2
0
Facial edema, hypersensitivity
1
0
Increased incisional bleeding
1
0

*Dogs may have experienced more than one type or occurrence of an event during the study.
**Most often occurred as a single event.

Study Conclusion
Subcutaneous administration of Onsior (robenacoxib) injection 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.

Onsior Tablets for Dogs: Safety

The margin of safety study supports the safe use for up to a maximum of 3 days.

Margin of Safety Study

Study Objective
To evaluate the toxicity and systemic exposure of robenacoxib tablets when administered to healthy adult dogs that received test article at 0.5, 1.5, and 2.5 times the maximum target exposure based on the inherent dose bands of the tablet sizes.
Study Animals
Intact male and female healthy Beagles, aged 6 to 7 months, weighing between 6.61 and 13.79 kg at the start of the study.
Study Conclusion
This 6-month laboratory study supports the safe use of Onsior Tablets for Dogs at a dose of 2 mg/kg/day for the labeled 3-day duration. Treatment-related findings included abnormal feces, effects on coagulation, retinal changes, neurological abnormalities, ECG changes, gross pathology changes and organ weight changes.