Veterinarians now have an FDA-cleared, pharmaceutical-grade, CGMP (or current good manufacturing practice) extended-release buprenorphine for use in four species: mice, rats, ferrets, and non-human primates (NHPs).
Fidelis Animal Health has received notification from the Food and Drug Administration (FDA) that Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is now also indexed for the control of post-procedural pain in NHPs.
“We are excited to bring this new NHP indication to veterinarians. Now, these caregivers have a three-day pain reliever that meets their high expectations for efficacy, safety, and quality,” says Michael Wells, board chair and CEO of Fidelis Animal Health.
Ethiqa XR is a form of buprenorphine that uses a patented lipid-based formulation that delivers up to 72 hours of clinical analgesia with one subcutaneous injection.
“Fidelipid LAI technology has been shown to provide safe, 72-hour analgesia in non-human primates,1,2” says Steven Leary, DVM, DACLAM, the company’s chief medical officer.
To learn more about the product, its important safety information and warning, visit the Ethiqa XR website.
References
- Fabian NJ, Mannion AJ, Jamiel M, Anderson DJ, Rower JE, Reilly CA, Menegas W, Muthupalani S, Ta C, Fox JG, Kramer R, Haupt JL. Evaluation and comparison of pharmacokinetic profiles and safety of two extended-release buprenorphine formulations in common marmosets (Callithrix jacchus). Sci Rep. 2023 Jul 22;13(1):11864. doi: 10.1038/s41598-023-38973-2. PMID: 37481609; PMCID: PMC10363172.
- Klein H, Levinson BL, Leary SL, Dobson G. A pharmacokinetic study of extended-release buprenorphine in cynomolgus monkeys (Macaca fasicularis). J Med Primatol. 2023 Dec;52(6):369-373. doi: 10.1111/jmp.12661. Epub 2023 Jul 11. PMID: 37432036.