Efficacy and Safety

Ethiqa XR® (buprenorphine extended-release injectable suspension) 1.3 mg/mL CIII is the only commercial pharmaceutical-grade extended-release buprenorphine FDA-indexed for the control of post-procedural pain in mice and rats.1  

  • Proven long-acting extended-release technology1
  • Delivers up to 3-days or up to 72 hours of demonstrated clinical analgesia in mice and rats with one subcutaneous injection1
  • Administration of a single injection minimizes animal stress and the inconvenience of multiple injections, helping improve animal welfare and reduce the variability of research
  • Manufactured in the United States under cGMPs using pharmaceutical-grade ingredients
  • Not compounded, not diluted
  • Favorable viscosity for easy administration
  • Simple to order
  • Complies with FDA GFI #256 “Compounding Animal Drugs from Bulk Drug Substances” and is available through national distributors
*current Good Manufacturing Practices regulated by the FDA
FAQS ABOUT ETHIQA XR

Up to 3 Days of Continuous Pharmaceutical Grade Relief

Tail Flick and PK Data Prove Efficacy following 1 Dose

Buprenorphine plasma concentrations were maintained above established levels for analgesia for up to 3-days or up to 72-hours in both mice and rats
read the ethiqa xr brochure

The Peace of Mind from a Product that is FDA-Indexed and Promotes Animal Welfare

Pharmaceutical grade, endotoxin-free

Demonstrated safety in mice1

  • Up to 5x dose, repeated 2x
  • No remarkable observations
  • No signs of pain
  • No adverse effect on respiration
  • No evidence of pica
  • No significant differences in organ weights
  • No meaningful differences in hematology and clinical chem values
  • No gross pathology findings; no histologic findings
  • No significant inflammation or edema

References:
1. FDA Expert Panel Report MIF Z-9000008-A-0000, p.3-53.
2. FDA Expert Panel Report—Rat Efficacy and Safety, p. 1-3.

Demonstrated safety in rats2

  • No adverse effects demonstrated in the TAS studies (repeated SC doses at 2x, 6x, and 10x dose)
  • No adverse effects in laboratory parameters (clinical observations, hematology, clinical chemistry, histopathology)
  • Rats should be maintained on paper or soft bedding to avoid ingestion of wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip-type bedding can be lethal in rats.

An Ethical Imperative

The Essential Need for Effective Pain Management in Laboratory Mice and Rats “The appropriate use of anesthetics, tranquilizers, analgesics, and nonpharmacologic interventions in research animals is an ethical and scientific imperative. Pain and distress are undesirable variables in most scientific research projects, and if not relieved, can result in unacceptable animal welfare and invalid scientific outcomes.” (emphasis added) — American College of Laboratory Animal Medicine (ACLAM), Position Statement on Pain and Distress in Research Animals

Pharmaceutical Grade Medications Help Limit Risks—Use When Available “The use of pharmaceutical grade chemicals and other substances ensures that toxic or unwanted side effects are not introduced into studies conducted with experimental animals. They should therefore be used, when available, for all animal-related procedures (USDA 1977b).” (emphasis added) — NIH Guide for the Care and Use of Laboratory Animals

Achieve Industry Welfare Standards

  • Leading lab animal medicine authorities increasingly recognize the ethical and scientific importance of protecting the welfare of research animals by providing rat and mouse analgesia at the highest level of quality.
  • Many industry organizations, including ACLAM, AALAS, and ASLAP, have developed official position statements recognizing the need to reduce the discomfort of lab animals with effective pain management.

LEARN MORE: For more information about laboratory industry associations and their positions regarding ethics and lab animal pain management, visit their websites at the links below:

American College of Laboratory Animal Medicine (ACLAM)
American Society of Laboratory Animal Practitioners (ASLAP)
Institute for Laboratory Animal Research (ILAR)
American Association for Laboratory Animal Science (AALAS)

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Boxed Warning

WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE

Abuse Potential

Ethiqa XR contains buprenorphine, a high-concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological 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 drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision.

Do not dispense Ethiqa XR.

Life-Threatening Respiratory Depression

The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.

Important Safety Information
For Rats and Mice:
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 on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression.

For Humans:
Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans.

For more information, consult the prescribing information including the boxed warning.