Publications
Dec 1, 2024
Trusted Safety & Efficacy
FDA requires the use of FDA-approved, conditionally approved, or indexed products whenever available. Ethiqa XR complies fully with FDA regulations, NIH requirements for pharmaceutical-grade products, and OLAW enforcement of humane care and compliance for NIH-funded studies.
By choosing Ethiqa XR, institutions stay aligned with FDA, NIH, and OLAW standards. It eliminates the risks of using compounded products.
- FDA prohibits compounded office stock of buprenorphine
- FDA requires indexed drugs over compounded alternatives unless medically justified
- NIH mandates pharmaceutical-grade compounds whenever possible
- OLAW ensures compliance for federally funded animal studies
- Compounded buprenorphine is not FDA-vetted for safety or efficacy
- Extra-label use of indexed products is prohibited
Demonstrated Efficacy and Safety for Pain Management
Ethiqa XR is FDA-indexed and indicated for the control of post-procedural pain for captive rodents, ferrets, laboratory rabbits, and non-human primates. Ethiqa XR is manufactured under cGMPs, meeting both regulatory and compliance needs. Each vial is manufactured to ensure consistency in its quality across vial to vial.
- FDA – indexed for legal market status
- Compliant with monitoring and reporting of adverse events and product complaints.
5
5 Years of proven Buprenorphine Pain Management
600 +
Serving 600+ Institutions Nationwide
72 hrs
Up to 72 Hours of Continuous Pain Relief
0:00
- Ethiqa XR provides peace of mind by aligning with FDA regulations, NIH, and OLAW guidance.
- Avoid the compliance risks tied to compounded buprenorphine. FDA-indexed status allows you to purchase office stock of Ethiqa XR. Ethiqa XR is complaint with FDA GFI #256 requirements
- Safe, Compliant, and Effective
- Compliant Access, Nationwide
- cGMP Production You Can Trust
- FDA-Indexed & Compliant
Ethiqa XR is an Indexed drug providing the only compliant option for long-acting buprenorphine for post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. Compounded buprenorphine is not FDA-vetted, not legal for office stock unless there is a medical rationale that the index drug or approved drug cannot meet, and not equivalent.
- FDA-indexed with FDA
- Complies with NIH pharmaceutical-grade compound guidance
- Aligns with OLAW oversight for grant-funded studies
- Avoids compliance risks of compounded formulations
- Trusted by 600+ institutions nationwide
- Safe, Compliant, and Effective
- Compliant Access, Nationwide
- cGMP Production You Can Trust
- FDA-Indexed & Compliant
Ethiqa XR is distributed through licensed national distributors, ensuring compliant, uninterrupted access. Unlike compounded buprenorphine, it does not require medical justifications—simplifying procurement while staying fully aligned with FDA regulations.
- Distributed legally as an indexed product
- No compounded office-stock restrictions
- Available nationwide
- Safe, Compliant, and Effective
- Compliant Access, Nationwide
- cGMP Production You Can Trust
- FDA-Indexed & Compliant
As an FDA-indexed drug, Ethiqa XR is manufactured under U.S. cGMP regulations. These standards ensure each vial meets strict federal requirements for identity, strength, quality, and purity.
- FDA-regulated cGMP manufacturing
- Rigorous quality management and monitoring
- Sterile product
- Safe, Compliant, and Effective
- Compliant Access, Nationwide
- cGMP Production You Can Trust
- FDA-Indexed & Compliant
Ethiqa XR complies fully with FDA indexing and GFI #256 guidance. In April 2023, FDA declined to allow buprenorphine HCl compounding for office stock—making Ethiqa XR the only legal option for long-acting buprenorphine in research rodents, rabbits, ferrets, and non-human primates.
- FDA-indexed and legally recognized
- Extra-label use prohibited
- Compounded buprenorphine not FDA-vetted for safety, efficacy, or quality
- Fully compliant with NIH, OLAW, and FDA guidance
Publications, Insights, Education & Evidence-Based Research
We’re Here to Support You
Your insights matter—because animal care starts with true collaboration. Ethiqa XR is a trusted, science-backed product for the control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. We are here to support you every step of the way. Connect with our team, ask questions, and stay informed. Together, we’re advancing animal welfare and raising the standard of care.
Contact Us
Real people providing dedicated support
Direct access to experienced veterinary experts
Backed by rigorous, proven research data
ETH.LP.212.01.D.ALL.AL
Boxed Warning
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
Important Safety Information
For Captive Rodents, Ferrets, Laboratory Rabbits, 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.
SA.EthiqaXR.060.05.2024