Efficacy and Safety

New Ethiqa XR = Confident Pharmaceutical Grade Quality

Gold Standard

Ethiqa XR sets the gold standard for quality as the first and only pharmaceutical grade, cGMP*-compliant, FDA-indexed extended-release buprenorphine analgesic indicated for use in mice and rats.1

  • Clinically significant blood levels for mouse and rat analgesia were demonstrated in studies conducted at Johns Hopkins University (see Figures 1 and 2).1
  • Learn more about groundbreaking research conducted at Johns Hopkins University School of Medicine in Baltimore, Maryland.

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
  • Helps manage pain in lab animals seen with short-acting buprenorphine formulations
  • 1 dose minimizes animal stress and the inconvenience of multiple injections, helping protect animal welfare and improve research results

*current Good Manufacturing Practices regulated by the FDA

Figure 1: Performance in Mice

efficacy-in-mice

3 Days of Pain Relief from a Single Injection

  • Proven in mice (see Figure 1)
  • FDA-indexed data

Figure 2: Performance in Rats

efficacy-in-rats

3 Days of Pain Relief from a Single Injection

  • Proven in Rats (see Figure 2)
  • FDA-indexed data

FDA-Indexed Safety Delivers Pure Peace of Mind

Assurance of FDA-reviewed safety data1

  • Demonstrated safety with no adverse reactions reported following surgery:
    • Up to 5x indicated Ethiqa XR mouse analgesia dose1
    • Up to 10x indicated Ethiqa XR rat analgesia dose1*
  • Dermal safety assurance
    • No crusty injection-site lesions1
  • 1-dose long-acting efficacy means fewer injections and improved animal welfare:
    • Less discomfort and stress for lab animals
    • Less handling by researchers

*Avoid use of wood chip bedding in rats for 3 days following treatment to minimize pica risk.

Reference:

1. Data on file, Fidelis Pharmaceuticals, LLC.

Confidence of Compliance with cGMPs*

Eliminates doubt regarding sourcing, quality, and data supporting lab analgesic choices

  • FDA-compliant supply chain and manufacturing
  • Pharmaceutical grade pure, sterile, endotoxin-free components
  • Made in USA (manufactured in Pennsylvania)

*current Good Manufacturing Practices regulated by the FDA

Pharmaceutical Grade Medications Provide Assurance and Protect Animal Welfare

Industry regulators and other constituents expect the use of pharmaceutical grade medications whenever they are available.

The use of pharmaceutical grade medications:

  • ensures a consistent highest level of purity and quality
  • enhances animal welfare
  • protects the scientific validity of study results

The most recent Guide for the Care and Use of Laboratory Animals published in 2011 by the National Research Council, supported by the National Institutes of Health (NIH) and other authorities, highlights the importance of pharmaceutical grade quality in research procedures.4

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). 4

NIH Guide for the Care and Use of Laboratory Animals

References:

1. ACLAM Position Statement on Pain and Distress in Research Animals. JAALAS. November 2016;55(6):821. Available at: https://www.aclam.org/about/position-statements. Accessed July 23, 2019.

2. Alleviating Pain and Distress in Laboratory Animals. American Association for Laboratory Animal Science website. Available at: https://www.aalas.org/about-aalas/position-papers/alleviating-pain-and-distress. Accessed July 24, 2019.

3. Position Statement, Animal Welfare Definition. American Society of Animal Laboratory Practitioners website. Available at: https://www.aslap.org/about. Accessed July 24, 2019.

4. Animal Care and Use Program. In: Guide for the Care and Use of Laboratory Animals. 8th ed. Washington, DC:The National Academies Press;2011:chap2,31. Available at: https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf. Accessed July 25, 2019.

Ethiqa XR Provides Confident Control

Get the Upper Hand in Pain-Free Rodent Analgesia

Worry-Free Pure Pain Relief

  • Ideal for postoperative, post-procedural, and tumor-related pain management

Easy to Use

  • Low-viscosity formula
  • Simple to draw
  • Smooth administration

Simple to Order Directly from Distributors

  • Easy ordering
  • Provides reliable access to the only pharmaceutical grade analgesic meeting or exceeding FDA-indexed standards for quality, safety, and efficacy

1 Injection

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

Ethiqa XR Dosing and Specifications

Species Specially formulated and FDA-reviewed with exclusive indication for use in laboratory mice and rats; no adjustments needed.
Packaging Supplied in multi-dose 3 mL vials
Buprenorphine concentration 1.3 mg/mL
Dosing for Mouse Analgesia Convenient single subcutaneous injection of 0.05 mL per 20-gram mouse (3.25 mg/kg body weight)
Dosing for Rat Analgesia Convenient single subcutaneous injection of 0.1 mL per 200-gram rat (0.65 mg/kg body weight)
Dose Repetition If needed, one additional dose of Ethiqa XR™ may be administered 72 hours after the initial dose per the product’s FDA-indexed label indicators.
Syringe/Needle Size For convenience and ease of administration, either a 0.5- or 1.0-mL syringe fitted with a 20- to 23-gauge needle may be used for injections.
Stability Approved for 12-month shelf life
Storage Store vial at 15° to 25°C (59° to 77°F) or refrigerate. Do not freeze.

An Ethical Imperative

The Essential Need for Effective 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)

Important Safety Information

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

Abuse Potential

This formulation 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. 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 this formulation.

Life-Threatening Respiratory Depression

The concentration of buprenorphine is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of this formulation. There are 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, this formulation should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.

Please see full Ethiqa XR™ Prescribing Information for additional Important Safety Information.