Postprocedural pain medication receives label expansion from FDA

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Officials with the FDA have modified the label for buprenorphine extended-release injectable suspension (Ethiqa XR; Fidelis Animal Health) 1.3mg/mL with an expansion to include indication for nonhuman primates (NHPs). Used for controlling post-procedural pain, the drug was previously approved for use in mice, rats and ferrets.^1,2

“We are excited to bring this new NHP indication to veterinarians. Now, these caregivers have a 3-day pain reliever that meets their high expectations for efficacy, safety, and quality,” Michael Wells, board chair and CEO, said in a news release.¹

Buprenorphine extended-release injectable suspension relies on Fidelis Animal Health’s patented Fidelipid LAI technology, a lipid-based formulation that delivers up to 72 hours of clinical analgesia with a single subcutaneous injection. “Fidelipid LAI technology has been shown to provide safe, 72-hour analgesia in nonhuman primates,” Steven Leary, DVM, DACLAM, chief medical officer of Fidelis Animal Health, said in the release.¹

This drug may cause sedation, decreased blood pressure, decreased heart rate,decreased gastrointestinal mobility, and respiratory depression in mice, rats, ferrets and NHPs, according to Fidelis Animal Health. Buprenorphine extended-release injectable suspension should be used with caution when administered with drugs that cause respiratory depression.Animals receiving buprenorphine extended-release injectable suspension should also be monitored for signs of decreased cardiovascular and respiratory function.¹

A qualified panel of veterinarians comprehensively reviewed published literature on buprenorphine and data from unpublished studies on the drug, according to the FDA. To support their assessment of the effectiveness and target animal safety of the drug, the panelists extrapolated information across species, because of the diversity of NHPs. As a result, these experts advised that when dosing patients for analgesia, it is important for investigators and veterinarians to carefully assess pain in each individual animal or experimental group.²

The panelists also used available information and personal experience to support dosing recommendations. They determined that a repeat dose of buprenorphine extended-release injectable suspension can be administered every 72 hours after the initial dose, if needed.²

As an FDA-reviewed and accepted product for commercialization, buprenorphine extended-release injectable suspension is manufactured in compliancewith current good manufacturing practice standards established by the agency. According to Fidelis Animal Health, the drug meets strict specifications to ensure the quality and integrity of the finished, sterile product.¹

Buprenorphine extended-release injectable suspension was launched in 2020. It is now used in more than 400 sites across the US including pharmaceutical companies, academic institutions, hospital systems, and government research facilities. The drug is available from the major national veterinary distributors.¹

References

1. Fidelis Animal Health announces Ethiqa XR label expansion. News release. Fidelis Animal Health. April 11, 2024. [email]
2. Freedom of information summary: Ethiqa XR. FDA. March 29, 2024. Accessed May 7, 2024. https://www.fda.gov/media/177916/download