Lack of adverse effects during a target animal safety trial of extended-release buprenorphine in fischer 344 rats

Alan Cowan, Rachel Sarabia Estrada, Gina Wilkerson, Patrick Mcknight, Michael Guarnieri

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Extended-release buprenorphine is an effective analgesic in laboratory animals, and its safety has been established in mice but not in rats. The authors used a target animal safety trial to evaluate the safety of extended-release buprenorphine in rats. Fischer 344 rats received post-surgical subcutaneous injections of 1.3 mg, 3.9 mg or 6.5 mg buprenorphine per kg body weight (two times, six times or ten times the intended dose, respectively), and their body weight, clinical signs and symptoms, clinical pathology and histopathology were monitored for 4 d. Body weight was not significantly different in rats that received buprenorphine compared with control rats. Signs of nausea-related behavior were observed in 25% of the rats treated with buprenorphine. Clinical pathology results for all rats were normal, and gross and microscopic histopathology examinations identified no substantial abnormalities, suggesting that this behavior was of minor consequence. Other adverse events previously reported to occur with opiate therapy, including weight loss and dermal lesions at drug injection sites, were not observed in this study. The results of this study show that post-surgical administration of an extended-release buprenorphine product is safe in Fischer 344 rats and does not necessarily cause substantial adverse effects, confirming that opiate therapy is a viable choice in laboratory animal medicine.

Original languageEnglish (US)
Pages (from-to)28-34
Number of pages7
JournalLab Animal
Volume45
Issue number1
DOIs
StatePublished - Dec 18 2015
Externally publishedYes

Fingerprint

buprenorphine
Buprenorphine
Inbred F344 Rats
adverse effects
Safety
Opiate Alkaloids
rats
animals
Clinical Pathology
Body Weight
Laboratory Animals
histopathology
body weight
laboratory animals
Subcutaneous Injections
drug injection
weight control programs
nausea
Nausea
Signs and Symptoms

ASJC Scopus subject areas

  • Animal Science and Zoology
  • veterinary(all)

Cite this

Lack of adverse effects during a target animal safety trial of extended-release buprenorphine in fischer 344 rats. / Cowan, Alan; Sarabia Estrada, Rachel; Wilkerson, Gina; Mcknight, Patrick; Guarnieri, Michael.

In: Lab Animal, Vol. 45, No. 1, 18.12.2015, p. 28-34.

Research output: Contribution to journalArticle

Cowan, Alan ; Sarabia Estrada, Rachel ; Wilkerson, Gina ; Mcknight, Patrick ; Guarnieri, Michael. / Lack of adverse effects during a target animal safety trial of extended-release buprenorphine in fischer 344 rats. In: Lab Animal. 2015 ; Vol. 45, No. 1. pp. 28-34.
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