Ethiqa XR now includes captive rodents and laboratory rabbits for 72-hour post-procedural pain management on its label
Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is now indicated for managing post-procedural pain in captive rodents and laboratory rabbits, according to Fidelis Animal Health, Inc, a commercial stage company developing, acquiring, and marketing pharmaceutical products for animals. A recent announcement by Fidelis Animal Health stated that the company had “received notification from the FDA” of the new indication.1
Ethiqa XR is an FDA-indexed, pharmaceutical-grade, extended-release buprenorphine injectable suspension. This opioid analgesic is intended for use by veterinarians in mice, naked mole rats, gerbils, hamsters, rats, chinchillas, guinea pigs, prairie dogs, ferrets, laboratory rabbits, and non-human primates.1,2 The product, according to Fidelis Animal Health, is produced under current Good Manufacturing (cGMP) regulations.1
“We are excited to bring these new indications to veterinarians in general and specialty practices, and in the research community. Ethiqa XR meets their high expectations for efficacy, safety, and quality, and makes it so much easier to comply with FDA GFI #256, which stresses the importance of using legal, FDA-indexed animal medications instead of compounded drugs for office stock and individual patient use" Michael Wells, board chair and CEO of Fidelis Animal Health, said in the announcement.1
According to Steven Leary, DVM, DACLAM, chief medical officer at Fidelis Animal Health, Ethiqa XR is a new form of buprenorphine that utilizes the company’s patented lipid-based formulation to provide 72 hours of clinical analgesia with one subcutaneous injection.
“Ethiqa XR is sterilized, with no harmful excipients, endotoxins, or microbial contamination,” Leary added.1
Ethiqa XR should only be administered by subcutaneous injection. The drug is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. It should not be used in animals with pre-existing respiratory conditions
There have been reports of death in mice when both nonsteroidal anti-inflammatory drugs (NSAIDs), like meloxicam and carprofen, and Ethiqa XR were administered together, according to Fidelis Animal Health.1
Avoid using wood chip bedding for rats after giving Ethiqa XR. “Pica involving wood chip type bedding can be lethal,” read the company announcement.1
Adverse effects from Ethiqa XR include sedation, low blood pressure, slower heart rate, reduced gastrointestinal movement, and respiratory depression. “Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR,” wrote Fidelis Animal Health in its announcement.1
According to the company, the safety of Ethiqa XR in pregnant, lactating, neonatal, or immunocompromised animals has not been studied.
The product was launched to laboratory veterinarians in 2020 and is now utilized by more than 500 institutions nationwide, including some top 10 pharmaceutical companies, academic institutions, hospital networks, and government research facilities.
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