Post-procedural pain medication gets label extension from the FDA

Veterinarians now have an Food and drug administration-cleared, pharmaceutical-grade, CGMP (or current superior manufacturing follow) prolonged-launch buprenorphine for use in 4 species: mice, rats, ferrets, and non-human primates (NHPs).

Fidelis Animal Health and fitness has obtained notification from the Food and drug administration that Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is now also indexed for controlling post-procedural ache in NHPs.

“We are thrilled to deliver this new NHP indicator to veterinarians. Now, these caregivers have a 3-working day pain reliever that satisfies their superior expectations for efficacy, protection, and good quality,” says Michael Wells, board chair and CEO of Fidelis Animal Wellness.

Ethiqa XR is a sort of buprenorphine using a patented lipid-centered formulation that provides up to 72 hrs of scientific analgesia with a single subcutaneous injection.

“Fidelipid LAI engineering has been revealed to present safe, 72-hour analgesia in non-human primates,1,2” claims Steven Leary, DVM, DACLAM, the company’s main health-related officer.

To discover additional about the item, protection details, and warning, take a look at the Ethiqa XR website.

References

  1. 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 prevalent marmosets (Callithrix jacchus). Sci Rep. 2023 Jul 2213(1):11864. doi: 10.1038/s41598-023-38973-2. PMID: 37481609 PMCID: PMC10363172.
  2. Klein H, Levinson BL, Leary SL, Dobson G. A pharmacokinetic review of extended-launch buprenorphine in cynomolgus monkeys (Macaca fasicularis). J Med Primatol. 2023 Dec52(6):369-373. doi: 10.1111/jmp.12661. Epub 2023 Jul 11. PMID: 37432036.