Efficacy

Field Study

The Clinical Field Study1 demonstrated a significantly higher proportion of inappetent dogs that received
ENTYCE® (capromorelin oral solution) had increased appetite as comparerd to dogs that received placebo.

Primary Endpoint: Owner Appetite Assessment

  • Success Rate on day 4
ParameterCapromorelinPlaceboP-Value
Treatment success–single-question assessment %*68.644.60.0078
Treatment success–Owner Appetite Assessment, %56.226.80.0071
Percent change in body weight, mean (SD)1.83 (2.8)0.11 (3.61)0.004
Percent change in Owner Appetite Assessment, mean (SD)73.4 (75.9)37.6 (53.9)0.0125
*A dog was considered a treatment success if the owner answered that their dog’s appetite was increased in response to the question, “Do you feel that during the study (over the 4 ± 1 days of treatment) your dog’s appetite was increased, no change or decreased?”
†Treatment success was defined as an increase in total score ? 5 from day 0 to day 3 ± 1 (scoring scale 5-25)

Field Study

The Clinical Field Study1 demonstrated a significantly higher proportion of inappetent dogs that received ENTYCE® (capromorelin oral solution) had increased appetite as comparerd to dogs that received placebo.

Primary Endpoint: Owner Appetite Assessment

  • Success Rate on day 4
ParameterCapromorelinPlaceboP-Value
Treatment success–single-question assessment %*68.644.60.0078
Treatment success–Owner Appetite Assessment, %56.226.80.0071
Percent change in body weight, mean (SD)1.83 (2.8)0.11 (3.61)0.004
Percent change in Owner Appetite Assessment, mean (SD)73.4 (75.9)37.6 (53.9)0.0125
*A dog was considered a treatment success if the owner answered that their dog’s appetite was increased in response to the question, “Do you feel that during the study (over the 4 ± 1 days of treatment) your dog’s appetite was increased, no change or decreased?”
†Treatment success was defined as an increase in total score ? 5 from day 0 to day 3 ± 1 (scoring scale 5-25)

Study Design

  • Blinded, placebo-controlled, multi-site study
  • 244 client-owned dogs enrolled, 2:1 randomization
  • Inappetence from a variety of causes
  • 3 mg/kg once daily oral liquid for 4 days
  • All dogs enrolled in the study were evaluated for adverse reactions throughout the course of the study

Adverse reactions reported in dogs administered ENTYCE oral solution compared with vehicle control
Adverse Reactions*ENTYCE (n=171)* n(%)Placebo (n=73)* n(%)
Diarrhea12 (7.0%)5 (6.8%)
Vomiting11 (6.4%)4 (5.5%)
Elevated blood urea nitrogen (BUN)7 (4.1%)2 (2.7%)
Polydipsia7 (4.1%)1 (1.4%)
Elevated phosphorus4 (2.3%)1 (1.4%)
Hypersalivation4 (2.3%)0 (0.0%)
Abdominal discomfort2 (1.2%)0 (0.0%)
Flatulence2 (1.2%)0 (0.0%)
Lethargy/depression2 (1.2%)0 (0.0%)
Nausea2 (1.2%)0 (0.0%)
Elevated creatinine1 (0.6%)1 (1.4%)
*The following adverse reactions were reported in <1% of dogs that were administered ENTYCE: hyperactivity, increased fecal volume, increased gut sounds and polyuria.

Conclusion

This study demonstrates that a ghrelin receptor agonist, ENTYCE, can stimulate appetite and increase body weight in a large population of client-owned dogs with reduced appetite of varying etiologies and was well-tolerated.

1Zollers B, Wofford JA, Heinen E, Huebner M, Rhodes L. A Prospective, Randomized, Masked, Placebo-Controlled Clinical Study of Capromorelin in Dogs with Reduced Appetite. J Vet Intern Med. 2016;30(6):1851-1857.

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IMPORTANT SAFETY INFORMATION: ENTYCE® (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the full Prescribing Information for more detail.

ENTYCE is Now Available

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