Controlled Substances News-Buprenorphine Extended Release for Rodents

In 2020, Fidelis Pharmaceuticals made available the first FDA-indexed extended-release buprenorphine formulation (Ethiqa XR®(link is external)) specifically for mice and rats.

Recent FDA guidance GFI #256 Compounding Animal Drugs from Bulk Drug Substances has been implemented that may impact the future use of Buprenorphine ER (formerly Buprenorphine SR).

Campus Veterinary Services encourages labs to review their use of extended-release buprenorphine and consider use of the FDA-approved Ethiqa XR® for future studies.

Below is a chart comparing the two Buprenorphine extended-release products:

 Ethiqa XRBuprenorphine ER/SR
FDA Approval StatusFDA-ApprovedCompounded  
Analgesia LengthUp to 72 hrs48-72 hrs
DosageMouse: 3.25 mg/kg SQ Rat: 0.65 mg/kg SQMouse: 0.5-1 mg/kg SQ Rat: 1-1.2 mg/kg SQ
Concentration1.3 mg/mL0.5, 1, and 3 mg/mL
Volume3 mL5 mL
Shelf Life Unopened24 monthsVaries by lot; typically 6-12 months from date of purchase
Shelf Life after Piercing Rubber Seal90 days30 days
Cost per vial*$415$150-190
How to ObtainInvestigators can purchase on their own with their individual DEA license through multiple suppliers/distributorsPrescription must be written by a veterinarian and drug ordered through Wedgewood Pharmacy
#doses per vial/cost per dose mouse/rat60/$7.00 for 20 g mouse 30/$12.50 for 200 g rat120/$1.75 for 20 g mouse 20/$9.50 for 200 g rat (Using the 1.0 mg/ml)

* As of 2/27/24. Price subject to change.

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