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
*current Good Manufacturing Practices regulated by the FDA
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
Pharmaceutical grade, endotoxin-free
Demonstrated safety in mice1
Demonstrated safety in rats2
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.
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
3 days of clinical analgesia with FDA-indexed efficacy and safety
The Essential Need for Effective Post-Procedural Pain Management in Laboratory Mice and Rats
WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE
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.