Fidelis Animal Health Announces Ethiqa XR® Label Expansion

Fidelis Animal Health, Inc. has announced that Ethiqa XR, an extended-release injectable buprenorphine, is now approved by the FDA for managing post-procedural pain in captive rodents and laboratory rabbits. This approval expands the use of Ethiqa XR, which already served animals such as mice, naked mole rats, gerbils, hamsters, rats, chinchillas, guinea pigs, prairie dogs, ferrets, and non-human primates.

Michael Wells, the Board Chair and CEO of Fidelis Animal Health, expressed enthusiasm about these new indications, noting that Ethiqa XR aligns with the high standards for safety, efficacy, and quality demanded by veterinarians. This medication helps veterinary practices and research communities adhere to FDA guidelines, specifically GFI #256, which emphasizes the importance of using FDA-approved animal medications over compounded alternatives.

Dr. Steven Leary, the Chief Medical Officer, highlighted that Ethiqa XR employs the patented Fidelipid LAI™ technology, a lipid-based formulation that ensures 72 hours of pain relief with a single subcutaneous injection. This product is manufactured following cGMP standards, ensuring it meets strict quality and potency specifications. It is sterilized and free of harmful excipients, endotoxins, or microbial contaminants.

Since its introduction to laboratory veterinarians in 2020, Ethiqa XR has seen substantial usage across over 500 institutions nationwide. These include top pharmaceutical companies, prestigious academic institutions, hospital systems, and several government research facilities. The use of Ethiqa XR is growing among veterinarians treating small mammals.

Ethiqa XR is widely available through major veterinary distributors like Covetrus, Patterson, MWI Animal Health, and Midwest Veterinary Supply.

IMPORTANT SAFETY INFORMATION
For captive rodents, ferrets, laboratory rabbits, and non-human primates, Ethiqa XR should only be administered via subcutaneous injection. It is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Animals with pre-existing respiratory issues should not be given Ethiqa XR. There have been reports of deaths in mice when non-steroidal anti-inflammatory drugs (NSAIDs) such as meloxicam and carprofen were administered alongside Ethiqa XR. Rats should not be housed on wood chip bedding after receiving Ethiqa XR, as pica involving wood chips can be fatal.

Potential side effects of Ethiqa XR include sedation, lowered blood pressure, slower heart rate, reduced gastrointestinal mobility, and respiratory depression. Caution is advised when administering Ethiqa XR with other drugs that depress respiration. Animals should be monitored closely for signs of reduced cardiovascular and respiratory function.

The safety of Ethiqa XR has not been studied in pregnant, lactating, neonatal, or immunocompromised animals.

For Humans:
Ethiqa XR is not for human use and should be kept out of reach of children and pets. It contains buprenorphine, a Schedule III controlled substance with a risk of abuse, overdose, and death. Proper handling procedures are essential to minimize misuse and diversion, including restricted access and appropriate disposal methods. Only trained veterinary staff should handle and administer Ethiqa XR, using protective clothing to avoid direct contact with human skin, eyes, oral, or other mucous membranes, which could absorb buprenorphine and cause adverse reactions.

Fidelis Animal Health is dedicated to leading the veterinary pharmaceutical industry by developing and marketing high-quality therapeutics and innovative solutions using their proprietary extended-release technology.