Fidelis Animal Health Announces Ethiqa XR® Label Expansion

Fidelis Animal Health has received notification from the Food and Drug Administration (FDA) that Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is now also indexed for the control of post-procedural pain in non-human primates (NHPs). With Ethiqa XR, veterinarians have an FDA-cleared, pharmaceutical grade, CGMP extended-release buprenorphine for use in four species: mice, rats, ferrets, and NHPs.

“We are excited to bring this new NHP indication to veterinarians. Now, these caregivers have a 3-day pain reliever that meets their high expectations for efficacy, safety, and quality. Ethiqa XR makes it so much easier to comply with the FDA’s new Food, Drug and Cosmetic Act GFI #256, which stresses the importance of using legal, FDA-indexed animal medications instead of compounded drugs1,” said Michael Wells, Board Chair and CEO.

Ethiqa XR is an innovative form of buprenorphine that uses Fidelis Animal Health’s Fidelipid LAITM technology, a patented lipid-based formulation that safely delivers up to 72 hours of clinical analgesia with just one subcutaneous injection. In the past, site reactions in NHPs have been reported to be quite common with other forms of buprenorphine2. “Fidelipid LAI technology has been shown to provide safe, 72-hour analgesia in non-human primates2,3,” says Dr. Steven Leary, the company’s Chief Medical Officer.

As an FDA-reviewed and accepted product for commercialization, Ethiqa XR is manufactured in compliance with cGMP standards, meeting strict specifications to ensure the quality and integrity of the finished product. Researchers and veterinarians do not need to be concerned about superpotency or sub-potency issues. Ethiqa XR is a sterile product with no harmful excipients, endotoxins, or microbial contamination. Ethiqa XR is easily and readily available from the major national veterinary distributors. For more information, visit www.ethiqaxr.com.

Since its launch in 2020, Ethiqa XR is currently being used in over four hundred institutions across the country, including those at the top ten pharmaceutical companies, many of the country’s elite academic institutions, hospital systems, and several government research facilities.

IMPORTANT SAFETY INFORMATION
For Mice, Rats, Ferrets, and Non-Human Primates:

Only administer Ethiqa XR® by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra- arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use in animals with pre-existing respiratory compromise.
Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.

Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.

Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, 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.

The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune- compromised animals.

For Humans:

Not for use in humans. Keep out of reach of children and pets.

Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids, which may lead to overdose and death.

Ethiqa XR should be handled appropriately to minimize the risk of misuse, abuse, addiction, and criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.

Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory staff trained in the handling of potent opioids. Wear protective clothing when administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions.

For more information, consult the Prescribing Information including the Boxed Warning.

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