Clinical Field Study
The results of this study demonstrated ENTYCE® (capromorelin oral solution) to be well-tolerated in a large population of client-owned dogs with varying ages and breeds with concomitant medications and clinical conditions.1 Capromorelin related events were mild with some adverse events consistent with a restored appetite.
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- 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(%)|
|Diarrhea||12 (7.0%)||5 (6.8%)|
|Vomiting||11 (6.4%)||4 (5.5%)|
|Elevated blood urea nitrogen (BUN)||7 (4.1%)||2 (2.7%)|
|Polydipsia||7 (4.1%)||1 (1.4%)|
|Elevated phosphorus||4 (2.3%)||1 (1.4%)|
|Hypersalivation||4 (2.3%)||0 (0.0%)|
|Abdominal discomfort||2 (1.2%)||0 (0.0%)|
|Flatulence||2 (1.2%)||0 (0.0%)|
|Lethargy/depression||2 (1.2%)||0 (0.0%)|
|Nausea||2 (1.2%)||0 (0.0%)|
|Elevated creatinine||1 (0.6%)||1 (1.4%)|
*The following adverse reactions were reported in <1% of dogs that were administered ENTYCE, increased fecal volume, increased gut sounds and polyuria.
12-Month Safety Study
Study results demonstrated that capromorelin was well-tolerated in healthy beagles at daily doses up to 40 mg/kg (17.5x the labeled dose) for 12 months, supporting a wide safety margin for use in dogs. Minimal toxicity was observed across multiple body systems when capromorelin was administered at doses substantially higher than the labeled dose over an extended period.2
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- Beagle dogs (n=32) received either oral placebo or 0.3, 7, or 40 mg/kg capromorelin oral solution administered once-daily for 12 consecutive months
- Safety was evaluated by physical examinations, including electrocardiogram (ECG), ophthalmic examinations and comprehensive clinical pathology
|Event, % of Dogs*||Placebo (n=8)||0.3 mg/kg (n=8)||7 mg/kg (n=8)||40 mg/kg (n=8)|
|Emesis||75% (1-3)||63% (1-2)||63% (1-4)||75% (1-6)|
|Loose stools||100% (1-41)||100% (5-32)||100% (2-220)||100% (1-46)|
|Excess salivation||13% (4)||0||88% (1-104)||100% (34-354)|
*Results in parentheses are reported as numbers of days in which adverse events were observed.
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.
2Zollers B, Huebner M, Armintrout G, Rausch-Derra LC, Rhodes L. Evaluation of the safety in dogs of long-term, daily oral administration of capromorelin, a novel drug for stimulation of appetite. J Vet Pharmacol Ther. 2016 Sep 25. Doi: 10.1111/jvp.12358
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.