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 Cats: Effectiveness and Safety

When administered postoperatively for a maximum of 3 days, Onsior Tablets for Cats have been shown to be effective and well-tolerated.

Field Effectiveness and Safety Study

Study Objective
A masked, randomized, placebo-controlled multi-center field study to evaluate the effectiveness and field safety of robenacoxib (tablets) when administered at a dose of 1 mg/kg once daily for 3 days for the control of postoperative pain and inflammation associated with reproductive surgery performed in conjunction with onychectomy (forelimbs only) in cats.
Study Animals
249 (110 males and 139 females) healthy, intact cats of various breeds between 6 months and 13 years of age, weighing between 2.5 and 7.4 kg.
Treatment Groups
Cats were randomized into two treatment groups in a 2:1 ratio (Onsior Tablets for Cats to placebo), and received whole Onsior Tablets for Cats or vehicle control tablets orally once daily for 3 days. Onsior Tablets for Cats were dosed at 1 mg/kg (0.45 mg/lb).
Surgical Preparation
All cats received perioperative fluids, butorphanol tartrate and a forelimb metacarpal four-point ring block as preanesthetic medication.
Drug Administration
All cats received the first treatment approximately 30 minutes prior to surgery, and the two subsequent daily doses approximately 24 hours and 48 hours later.
Pain Assessments
Pain was evaluated at baseline and at predetermined postoperative intervals to assess overall response to treatment. At any time, if an animal was determined to be in discomfort, rescue pain medication could be administered. Cats receiving postoperative rescue pain treatment were considered treatment failures. The following pain categories were assessed:
  1. Posture
  2. Behavior
  3. Pain upon palpation
  4. Overall pain control
Statistical Methods
Cats that received rescue pain medication 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=0.0476) in the proportion of treatment successes in the Onsior Tablets for Cats group compared to the control group was observed.

83.5% (robenacoxib) vs. 53.8% (vehicle control). 27/164 of cats in the robenacoxib group and 37/80 in the control group were considered treatment failures, respectively.

The analysis showed that for OVH or castration incision site pain, there were statistically significant (P<0.05) differences in incision site pain scores at assessment times 5 and 8 hours, indicating less pain in the Onsior group, and in social behavior scores and posture scores at times 3.5 and 8 hours, indicating less pain in the Onsior group.
Adverse Reactions
The most commonly reported adverse reactions in cats treated with Onsior Tablets for Cats were surgical site bleeding, infected surgery sites, lethargy and inappetence.

Adverse Reactions in the postoperative pain field study*

Adverse Reaction

Onsior 6 mg Tablets for Cats (robenacoxib) N=167

Placebo (vehicle control) N=82

Incision site bleeding
7
1
Incision site infection
6
2
Inappetance, weight loss
4
2
Decreased activity, lethargy
4
1
Vomitting
4
1
Cystitis, hematuria
3
0
Hematochezia, diarrhea
3
1
Hair loss, excoriation, bruising
2
0
Respiratory, cardiac arrest
1
0
Incoordination, weakness
1
1
Death
0
1

*Cats may have experienced more than one of these signs during the study.

Study Conclusion
Administration of Onsior Tablets for Cats at a dose of 1 mg/kg (0.45 mg/lb) once daily for up to 3 days, with the first dose administered approximately 30 minutes prior to surgery, was effective and well-tolerated for the control of postoperative pain and inflammation with orthopedic surgery, ovariohysterectomy and castration in cats.

Onsior injection: Effectiveness and Safety

Field Effectiveness and Safety Study

Study Objective
A masked, randomized, placebo-controlled, multi-site field study was conducted to evaluate the safety and 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 orthopedic surgery, ovariohysterectomy and castration in cats.
Study Animals
349 (162 males and 187 females) client-owned healthy, intact cats of various breeds (between 4 months and 7 years of age, weighing between 2.5 and 6.0 kg) were presented for ovariohysterectomy or castration in conjunction with onychectomy (forelimbs only). Effectiveness was evaluated in 303 cats and field safety in 317 cats.
Treatment Groups
Cats were randomized into two treatment groups in a 1:1 ratio, and received either Onsior injection or placebo once daily for 3 days.
Drug Administration
The drug or the placebo was administered approximately 30 minutes prior to surgery, along with preanesthetic medications. The two subsequent daily doses were given approximately 24 hours and 48 hours later.
Surgical Preparation
All cats received perioperative fluids, butorphanol and a forelimb metacarpal four-point ring block as preanesthetic medication.
Pain Assessments
Pain was evaluated at baseline and at predetermined postoperative intervals to assess overall response to treatment. At any time, if an animal was determined to be in discomfort, rescue pain medication could be administered. Cats receiving postoperative rescue pain treatment were considered treatment failures. The following pain categories were assessed:
  1. Posture
  2. Behavior
  3. Pain upon palpation
  4. Overall pain control
Study Results
Safety
Subcutaneous administration of Onsior injection for 3 days was well-tolerated with orthopedic surgery, ovariohysterectomy and castration in cats.

Efficacy
A statistically significant difference (p=0.0370) was observed in the proportion of treatment successes in the Onsior Injection group compared to the control group.

Analyses showed statistically significant differences (p<0.05) for ovariohysterectomy and castration incision site pain, overall pain and behavior scores at 1, 3, 5 and 8 hours postsurgery, and pain in the paws and posture scores at 3, 5 and 8 hours postsurgery, indicating less pain in the Onsior injection group than in the placebo group.
Adverse Reactions
The most commonly reported adverse reactions in cats treated with Onsior injection were infected incision sites, increased incision site bleeding, vomiting, inappetence and lethargy.

Adverse Reactions in the Postoperative Pain Field Study*

Adverse Reaction*

Onsior N=174**

Control (0.9% physiological saline) N=175

Incision site infection, dihiscence
9
0
Increased incision site bleeding
6
4
Vomitting
5
0
Decreased appetite
4
3
Lethargy (after day of surgery)
4
2
UTI
2
0
Coughing
1
0
Fever
1
0
Semiconscious***
1
0
Soft stool, diarrhea
0
2

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

**One Onsior cat suffered an anesthetic-related death.

***Semiconscious cat fully recovered.

Study Conclusion
Subcutaneous administration of Onsior injection at a dose of 2 mg/kg (0.91 mg/lb) once daily for up to 3 days was well-tolerated and effective for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats.

Onsior Tablets for Cats: Safety

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

Margin of Safety Study

Study Objective
To evaluate the safety of robenacoxib tablets when administered to cats that received the test article at 1 (2.4 mg/kg), 3 (7.2 mg/kg), and 5 (12 mg/kg) times the maximum targeted exposure once daily.
Study Animals
8 month-old, healthy cats.
Adverse Reactions
The most common adverse reactions were vomiting, decreased activity, injected sclera and soft stools.
Study Conclusion
This 6-month laboratory study supports the safe use of Onsior Tablets for Cats for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats for a maximum of 3 days at the recommended dose of 1mg/kg (0.45mg/lb).