Efficacy and Safety

New Ethiqa XR® = Confident Pharmaceutical Grade Quality

Ethiqa XR is the only pharmaceutical grade, cGMP*-compliant, FDA-indexed extended-release buprenorphine analgesic indicated for the control of post-procedural pain in mice and rats.1

The only FDA-indexed cGMP* extended-release technology1

  • Proven long-acting extended-release technology1
  • Delivers up to 72 hours of demonstrated clinical analgesia in mice and rats with 1 subcutaneous injection1
  • 1 dose minimizes animal stress and the inconvenience of multiple injections, helping improve animal welfare and reduce variability of research

*current Good Manufacturing Practices regulated by the FDA

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 3 days in both mice and rats

Pure Peace of Mind with FDA-Indexed Safety Affirmed by FDA

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

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.

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.

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

Feel The Confidence

  • FDA-indexed for use on mice and rats
  • Pharmaceutical grade
  • FDA-reviewed safety and 72-hour efficacy with 1 injection
  • cGMP
  • Simple to order
  • Favorable viscosity for easy administration
  • Dermal safety
  • Improved animal welfare with minimal handling

1 Injection

3 days of clinical analgesia with FDA-affirmed efficacy and safety

Achieve Industry Welfare Standards

The Essential Need for Effective Post-Procedural Pain Management in Laboratory Mice and Rats

  • 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 for reducing the discomfort of lab animals with effective pain management.
Ethiqa XR - Pain Management in Lab Animals

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)

 

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, Not for use in humans

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.