ETHIQA XR® PUBLICATIONS

PUBLICATIONS

Extended-release buprenorphine, an FDA-indexed analgesic, attenuates mechanical hypersensitivity in rats.

Alamaw, E. D., Franco, B., Jampachaisri, K., Huss, M. K., & Pacharinsak, C. (2021). Extended-Release Buprenorphine, an FDA-indexed Analgesic, Attenuates Mechanical Hypersensitivity in Rats. Journal of the American Association for Laboratory Animal Science, 60(5), 314. Poster presented at AALAS National Conference, October 2021; Kansas City, MO.

Extended-release buprenorphine, an FDA-indexed analgesic, attenuates mechanical hypersensitivity in rats (rattus norvegicus).

Alamaw ED, Franco BD, Jampachaisri K, Huss MK, Pacharins ak C. Extended-release Buprenorphine, an FDAindexed Analgesic, Attenuates Mechanical Hypersensitivity in Rats (Rattus norvegicus). J Am Assoc Lab Anim Sci. 2022 Jan 1;61(1):81-88. doi: 10.30802/AALAS-JAALAS-21-000081. Epub 2021 Dec 16. PMID: 34903316; PMCID: PMC8786384.

Buprenorphine does not attenuate postoperative hypersensitivity in NSG mice.

J Arthur, ED Alamaw, K Jampachaisri, C Nagamine, MK Huss, C Pacharinsak Institution(s): Department of Comparative Medicine, Stanford University, Stanford, CA; Faculty of Science, Naresuan University, Phitsanulok, Thailand. Poster presented at AALAS National Conference, October 2021; Kansas City, MO.

Assessment of the Safety and Efficacy of Pre-emptive Use of Extended-release Buprenorphine for Mouse Laparotomy.

Chan G, Si C, Nichols MR, Kennedy L. Assessment of the Safety and Efficacy of Pre-emptive Use of Extended-release Buprenorphine for Mouse Laparotomy. J Am Assoc Lab Anim Sci. 2022 Jul 1;61(4):381-387. doi: 10.30802/AALAS-JAALAS-22-000021. Epub 2022 Jul 8. PMID: 35803705; PMCID: PMC9674008.

Evaluation and comparison of pharmacokinetic profiles and safety of two extended‑release buprenorphine formulations in common marmosets (Callithrix jacchus)

Fabian, Niora J, et al. Scientific Reports. (2023) 13:11864

Safety and efficacy of buprenorphine for analgesia in laboratory mice and rats

Guarnieri et al. Safety and efficacy of buprenorphine for analgesia in laboratory mice and rats. Lab Animal, 41(11): 337-343; 2012. 

Review of long-acting parenteral analgesics for mice and rats.

Huss MK, Pacharinsak C. A Review of Long-acting Parenteral Analgesics for Mice and Rats. J Am Assoc Lab Anim Sci. 2022 Nov 1;61(6):595-602. doi: 10.30802/AALAS-JAALAS-22-000061. Epub 2022 Nov 15. PMID: 36379476; PMCID: PMC9732779.

Comparative Pharmacokinetics and Injection Site Histopathology in Nude Mice Treated with Long-acting Buprenorphine Formulations

Illario JA, Osborn KG, Garcia AV, Sepulveda YJ, Momper JD, Kiel JW, Kirihennedige AS, Sun SA, Richter PJ. Comparative Pharmacokinetics and Injection Site Histopathology in Nude Mice Treated with Long-acting Buprenorphine Formulations. J Am Assoc Lab Anim Sci. 2023 Mar 1;62(2):147-152. doi: 10.30802/AALAS-JAALAS-22-000102. Epub 2023 Feb 22. PMID: 36813268; PMCID: PMC10078935.

Pharmacokinetics of Single-Dose Buprenorphine, Butorphanol, and Hydromorphone in the Domestic Ferret (Mustela putorius furo)

Katzenbach et al. Pharmacokinetics of single-dose buprenorphine, butorphanol, and hydromorphone in the domestic ferret (Mustela putorius furo). J Exotic Pet Medicine 27 (2018), pp 95-102.

A Comparison of Three Buprenorphine Formulations for Management of Acute Post Operative Pain in Mice

Kirkpatrick et al. A Comparison of Three Buprenorphine Formulations for Management of Acute Post-Operative Pain in Mice. Poster presented at AALAS National Meeting, October 2023, Salt Lake City, UT. (Novartis)

A pharmacokinetic study of extended-release buprenorphine in cynomolgus monkeys (Macaca fasicularis)

Klein H, Levinson BL, Leary SL, Dobson G. A pharmacokinetic study of extended-release buprenorphine in cynomolgus monkeys (Macaca fasicularis). J Med Primatol. 2023;00:1-5. doi:10.1111/jmp.12661

 

Pharmacokinetic and histopathologic study of an extended-release, injectable formulation of buprenorphine in Sprague–Dawley rats.

Levinson, B. L., Leary, S. L., Bassett, B. J., Cook, C. J., Gorman, G. S., & Coward, L. U. (2021). Pharmacokinetic and Histopathologic Study of an Extended-Release, Injectable Formulation of Buprenorphine in Sprague–Dawley Rats. Journal of the American Association for Laboratory Animal Science, 60(4), 462–469. doi: 10.30802/AALAS-JAALAS-20-000149

Comparing Three Formulations of Buprenorphine in an Incisional Pain Model in Mice

Lopez-Echeverria, Giselle et al. Comparing Three Formulations of Buprenorphine in an Incisional Pain Model in Mice. JAALAS 62 (6): 531-537 (2023), https://doi.org/10.30802/AALAS-JAALAS-23-000011]

Efficacy and duration of various buprenorphine preparations in a mouse hind paw incision model of pain.

Mangosing, S. J., Martin, H. R., Lieggi, C., Willis, D. E., & Lipman, N. S. (2021). Efficacy and Duration of Various Buprenorphine Preparations in a Mouse Hind Paw Incision Model of Pain. Abstracts of Scientific Papers 2021 AALAS National Meeting, P350.

Lipid bound extended-release buprenorphine (high and low doses) and sustained release buprenorphine effectively attenuate post-operative hypersensitivity in an incisional pain model in mice (mus musculus).

Navarro, K., Jampachaisri, K., Huss, M., & Pacharinsak, C. (2021). Lipid bound extended release buprenorphine (high and low doses) and sustained release buprenorphine effectively attenuate post-operative hypersensitivity in an incisional pain model in mice (Mus musculus). Animal Models and Experimental Medicine, 4(2), 129-137. https://doi.org/10.1002/ame2.12157

Lipid bound extended-release buprenorphine effectively attenuates post-operative hypersensitivity in an incisional pain model in mice (mus musculus).

Navarro, K., Jampachaisri, K., Huss, M., & Pacharinsak, C. (2020). Lipid Bound Extended-release Buprenorphine Effectively Attenuates Postoperative Hypersensitivity in an Incisional Pain Model in Mice (Mus musculus). Abstracts of Scientific Papers 2020 AALAS National Meeting, P105.

Pharmacokinetics and Efficacy of Extended-Release Buprenorphine for Post-Operative Pain Management in the Domestic Ferret (Mustela putorius furo)

Plunkard et al. Pharmacokinetics and efficacy of extended-release buprenorphine for post-operative pain management in the domestic ferret (Mustela putorius furo). AALAS National Meeting platform session, October 2023, Salt Lake City, UT.

Post-surgical recovery assessment of mice treated with extended-or sustained-release buprenorphine.

Saenz, M., Bloom-Saldana, E. A., Fueger, P. T., Ermel, R., & Finlay, J. (2020). Postsurgical Recovery Assessment of Mice Treated with Extended- or Sustained-Release Buprenorphine. Abstracts of Scientific Papers 2020 AALAS National Meeting, P342.

Extended-release buprenorphine effectively attenuates laser-induced thermal hypersensitivity in an incisional model in neonatal rats.

Zhang, M., Alamaw, E. D., Jampachaisri, K., Huss, M. K., & Pacharinsak, C. (2021). Extended Release Buprenorphine Effectively Attenuates Laser-Induced Thermal Hypersensitivity in an Incisional Model in Neonatal Rats. In Abstracts of Scientific Papers 2021 AALAS National Meeting, P338. Stanford University, Cupertino, CA; Department of Mathematics, Naresuan University, Phitsanulok, Thailand. AALAS National Meeting. (2021). Title of the Abstract. In Abstracts of Scientific Papers 2021 AALAS National Meeting, P338. 

PUBLICATIONS ON ANIMALGESIC

The Role of Drug-Lipid Interactions on the Disposition of Liposome-Formulated Opioid Analgesics In Vitro and In Vivo

Bethune et al., The role of drug-lipid interactions on the disposition of liposome-formulated opioid analgesics in vitro and in vivo. Anesth Analg. 93(4):928-33; 2001.

A Long-Term Study of a Lipid-Buprenorphine Implant in Rats.

Guarnieri M, Brayton C, Tyler BM. Published online July 9, 2018. doi: 10.1155/2018/2616152

Buprenorphine analgesia in mice.

Itzoe ML, Ye X, Sarabia-Estrada R, et al. Int J Res Health Sci. 2018;6(1):2169-2177.

Subcutaneous Implants of a Cholesterol-Triglyceride-Buprenorphine Suspension in Rats.

Laudadio, V., Guarnieri, M., Brayton, C., Sarabia-Estrada, R., Tyler, B., McKnight, P., & DeTolla, L. (2017). Subcutaneous Implants of a Cholesterol-Triglyceride-Buprenorphine Suspension in Rats. Journal of Veterinary Medicine, 2017, 4:1-11., 3102567. 

Engineering Solid Lipid Nanoparticles for Improved Drug Delivery: Promises and Challenges of Translational Research

Mishra et al. Engineering solid lipid nanoparticles for improved drug delivery: promises and challenges of translational research. Drug Delivery and Transl. Res, 2: 238-253; 2012.

Association of Nausea with Buprenorphine Analgesia for Rats.

Sarabia-Estrada R, Cowan A, Tyler BM, Guarnieri M. Lab Animal. 2017;46:242-244.

A Thermal latency studies in opiate-treated mice.

Schildhaus N, Trink E, Polson C, et al. J Pharm Bioallied Sci. 2014;6(1)43-47.

Safety studies of post-surgical buprenorphine therapy for mice.

Traul KA, Romero JB, Brayton C, DeTolla L, Forbes-McBean N, Halquist MS, Karnes HT, Sarabia-Estrada R, Tomlinson MJ, Tyler BM, Ye X, Zadnik P, Guarnieri M. Safety studies of post-surgical buprenorphine therapy for mice. Lab Anim. 2015 Apr;49(2):100-10. doi: 10.1177/0023677214554216. Epub 2014 Oct 10. PMID: 25305141. 

LP.EthiqaXR.009.04.24
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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