Pregabalin: what the FDA reviewed for dog products
1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Pregabalin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- LIAVIUM™-CA1 (NADA/ANADA 141-606)
LIAVIUM™-CA1 NADA 141-606, Original approval, May 12, 2026; sponsor TriviumVet; species: Dogs; foi_id 18446; FDA PDF
Indication
Management of pain and clinical signs associated with Chiari-like malformation and syringomyelia in dogs (conditional approval).
Dose regimen
5-10 mg/kg, Oral, Twice daily, Administer with food; may be given concurrently with an NSAID; 90 mg tablet scored, 30 mg and 180 mg tablets not to be split; dogs under 3 kg cannot be accurately dosed.
Administer LIAVIUM™-CA1 chewable tablets at 5-10 mg/kg orally twice daily. LIAVIUM™-CA1 should be administered with food.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| other | No accumulation with repeat dosing over the 14-day period | Sanchis-Mora et al. 2019 clinical trial: 5 mg/kg pregabalin oral solution twice daily; plasma sampled at baseline and 90±9 min post-dose at Visits 1-3 | The pharmacokinetic analysis of plasma pregabalin concentration demonstrated that drug accumulation did not occur with repeat dosing during the 14-day period. |
Target-animal safety
dose multiples 0X (sham), 1X (10 mg/kg), 3X (30 mg/kg), 5X (50 mg/kg); duration 90 days, twice daily (fed); animals Thirty-six Beagle dogs (four groups).
Objective: To evaluate the safety of LIAVIUM™-CA1 (pregabalin chewable tablets) at 10, 30, and 50 mg/kg administered orally, twice daily for 90 days. Study Animals: Thirty-six Beagle dogs aged 9 to 23 months old and weighing 6.3 to 16 kg at the start of acclimatization were included in the study.
| Finding | Quote |
|---|---|
| Dose-dependent decrease in rectal temperature in the 5X group (lowest 98.1 °F) | There was a dose dependent effect of LIAVIUM™-CA1 on rectal temperature in the 5X group. Dogs in the 5X group had more individual instances of rectal temperatures ≤99.9 °F, with the lowest observed temperature value of 98.1 °F. |
| Glycosuria without hyperglycemia in five treated dogs (one 1X, two 3X, two 5X); mechanism unknown | Glycosuria without hyperglycemia occurred in five dogs administered LIAVIUM™-CA1 (one 1X dog, two 3X dogs, and two 5X dogs); the mechanism of action for this finding is unknown. |
| Dull behavior in one pair of 5X dogs on Day 63 (1 h post evening dose) | Dull behavior was noted on Day 63 at the evening 1-hour post dose observation for one set of 5X group pair-housed dogs. |
| No clinically relevant hematology, serum chemistry or coagulation differences | There were no clinically relevant differences in hematology variables, serum chemistry variables, activated prothrombin time (APTT), prothrombin time (PT), or fibrinogen in the 1X, 3X, and 5X groups compared to baseline and the control group. |
| No effect on gross necropsy or histopathology | There were no effects of LIAVIUM™-CA1 administration on gross necropsy or histopathology, including bone marrow microscopic assessments. |
| Overall treatment-related findings: low rectal temperature, glycosuria, dull mentation | Treatment-related findings included low rectal temperature, glycosuria, and dull mentation. |
Effectiveness
Reasonable expectation of effectiveness based on a published prospective, randomized, double-masked, placebo-controlled crossover trial (Sanchis-Mora et al. 2019) in client-owned Cavalier King Charles Spaniels with symptomatic CM/SM: 5 mg/kg pregabalin oral solution (not final formulation) or placebo twice daily for 14±4 days per phase with concurrent NSAID.; n = nine (one placebo-phase dog removed for unrelated diarrhea); primary endpoint: Daily owner numerical rating scale (NRS) pain scores and quantitative sensory testing (STEP) by the investigator; result: NRS pain scores lower during the pregabalin phase than baseline and placebo; higher mechanical thresholds and improved cold latency with pregabalin; supports a minimum dose of 5 mg/kg twice daily with an NSAID.
The dog owner assessed daily NRS pain scores were lower during the pregabalin phase compared to baseline and the placebo phase, indicating that the dogs were less painful during the pregabalin phase.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Sedation (Sanchis-Mora trial, 5 mg/kg BID) | two dogs | Sedation was reported in two dogs. No other adverse reactions were reported. | |
| Reduced activity, ataxia, increased appetite, somnolence, increased water intake (Thoefner trial, 13-19 mg/kg per dose) | Adverse reactions that occurred more frequently in dogs receiving pregabalin compared to placebo were reduced activity, ataxia, increased appetite, somnolence, and increased water intake. |
Extraction notes: Conditional approval (section 571): effectiveness is 'reasonable expectation' from literature, not a sponsor field study; the Sanchis-Mora trial used an oral solution, not the final chewable tablet. TAS study TRIV-29 had 8 dogs per group (4 females, 4 males); the figure is not placed in n_animals because the design quote spells the total out in words. No canine PK parameter values are reported.
Reproduce: foi_structured_search(query="Pregabalin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).