ZORBIUM® APPROVAL STUDIES – KEY FINDINGS SUMMARY
Phase 2 & Phase 3 Clinical Studies Analysis
December 13, 2025
PHASE 2 STUDY (115 cats, 8 sites, 6 states)
Study: Clark et al., 2022 – Dose-finding study to select dose for Phase 3
GLARING ERRORS & OMISSIONS:
Population Issues:
- ❌ Only healthy cats (excluded all with health problems)
- ❌ Youngest cats: 4 months old = KITTENS (kittens = birth to 12 months)
- ❌ Mean age: 10.7 months (still kittens)
- ❌ All cats declawed (extreme pain procedure)
- What they NEVER showed:
- ❌ Adverse events by breed
- ❌ Adverse events by coat color
- ❌ Adverse events by age group
- ❌ Adverse events by weight category
- ❌ Breed-specific reactions
What They Found But Dismissed:
- ✓ 75% had hyperthermia (max temp: 105.9°F/41.1°C)
- ✓ 50% sedated at recovery
- ✓ 15.8% had dysphoria
- ✓ 85% had tachypnea (fast breathing)
- ✓ 13-22% “unacceptable” recovery (paddling, swimming motions)
- ✓ One cat withdrawn for persistent fever (28 hours of 39.7-39.8°C)
- ✓ 33.3% treatment failure rate (high-dose group)
Study Design Flaws:
- ❌ 96-hour study only (4 days) – no follow-up after discharge
- ❌ Protocol changed mid-study (cats not waking up properly from anesthesia)
- ❌ Non-validated pain scale (admitted in study)
- ❌ All authors = Nexcyon employees
- ❌ Funded by Nexcyon + Elanco
Their Conclusion:
“No differential safety observations that support selection of a lower dose”
Reality: They saw dangerous temps, high failure rates, prolonged sedation — approved it anyway.
PHASE 3 STUDY (228 cats, 12 sites, 7 states)
Study: Clark et al., 2022 – THE FDA APPROVAL STUDY
GLARING ERRORS & OMISSIONS:
Population Issues:
- ❌ Only healthy cats (excluded ALL with health problems)
- ❌ Youngest cats: 4 months old = KITTENS
- ❌ Mean age: 10.3 months (still kittens)
- ❌ All cats declawed (maximum pain procedure)
- ❌ Oldest cat: 60 months (5 years) – no geriatric cats tested
What They Found But Dismissed:
- ✓ 74.3% had hyperthermia (vs 56.9% placebo) – STATISTICALLY SIGNIFICANT p<.05
- ✓ Max temps: 105.4°F (40.8°C) in BOTH groups
- ✓ 56.6% sedation
- ✓ 17.7% dysphoria
- ✓ 85% breathing problems
- ✓ 19% treatment failure rate (even with declawing + pre-op pain meds)
- ✓ 5 cats pulled for hyperthermia (3 Zorbium®, 2 placebo) – given dexamethasone
- ✓ 1 cat pulled for aggressive/fractious behavior
- ✓ Recovery times 5-6 minutes longer (statistically significant)
Study Design Flaws:
- ❌ 96-hour study only – cats discharged while drug still active (half-life 78-91 hours)
- ❌ No follow-up after discharge
- ❌ Non-validated pain scale (admitted in study)
- ❌ All authors = Nexcyon employees (same team as ALL 5 studies)
- ❌ Funded by Nexcyon + Elanco
- ❌ No independent verification
Exclusions (Who WASN’T Tested):
- ❌ Sick cats (liver, kidney, heart, respiratory disease)
- ❌ Kittens under 4 months
- ❌ Geriatric cats (oldest = 5 years)
- ❌ Pregnant/lactating cats
- ❌ Cats with seizure history
- ❌ Cats with “any clinically relevant abnormalities”
- ❌ “Fractious” (stressed) cats
Their Conclusion:
“Safe and effective… success rate approximately 80%”
Reality:
- 1 in 5 cats FAILED treatment even under ideal conditions
- Hyperthermia statistically higher in Zorbium® group
- Now used on sick cats, geriatric cats, stressed cats — all excluded from studies
THE SMOKING GUNS – DIRECT QUOTES
They Admitted It Doesn’t Work Well:
“TBS treatment alone may not be sufficient for the control of post-operative pain in some cats”
— Phase 3 Study, Page 64
They Knew About Hyperthermia:
“Clinicians should be aware that TBS may cause small and transient increases in body temperature”
— Phase 3 Study, Page 62
They Used Non-Validated Pain Scale:
“A potential limitation of the present study is that a validated pain scale that underwent a priori evaluation of content, criterion, construct, responsiveness, and reliability was not used”
— Phase 3 Study, Page 62
They Only Tested Healthy Cats:
“Cats were excluded if they had a history of blood dyscrasia, hepatic, renal or cardiac disease, seizures, or any other clinically relevant medical abnormalities”
— Phase 3 Study, Page 54
WHAT THEY SAW vs WHAT’S HAPPENING NOW
| Documented in Studies | Real-World Reports |
|---|---|
| Hyperthermia (74.3%) | Cats dying from hyperthermia |
| Max temps 105.9°F | Fever-related deaths |
| Sedation (50-56.6%) | “Catatonic” cats for days |
| Dysphoria (15.8-17.7%) | Aggressive, hyperactive, can’t sleep 72+ hours |
| Unacceptable recovery (paddling, swimming) | Neurological damage, can’t walk |
| One cat too aggressive to assess | Violent behavior changes |
| 19-33% treatment failures | Drug doesn’t work in 1 out of 5 cats |
CRITICAL NUMBERS
Study Population:
- Phase 2: 115 cats
- Phase 3: 228 cats
- Total tested for approval: 343 cats
Study Duration:
- 96 hours (4 days) observation
- Drug half-life: 78-91 hours
- Cats discharged while drug still active
- ZERO follow-up after day 4
Success/Failure Rates:
- Phase 2 high-dose: 66.6% success (33.3% failure)
- Phase 3: 81% success (19% failure)
- Even under ideal conditions: 1 in 5 cats needed rescue meds
Real-World Adverse Events (FDA Data):
- 2,800+ adverse event reports
- 300+ cat deaths (as of June 2025, per FDA)
- When cats have adverse reactions: 1 in 9 dies (11% fatality rate)
THE KITTEN DECEPTION
Label Says:
“The safe use of ZORBIUM® has not been evaluated in cats younger than four months old”
What This Means:
- Sounds like kittens weren’t tested
- Creates impression of adult-only drug
- Veterinarians assume “4 months+” = safe for young cats
Reality:
- Both studies included 4-month-old cats
- 4 months = KITTEN (kittens = birth to 12 months)
- Mean age: 10.3 months (still kittens)
- Safety study title: “Target Animal Safety Study… in Four-Month-Old Cats” (NCY05-L-18)
This is deliberate pharmaceutical wording to obscure the fact that kittens WERE tested.
CONFLICT OF INTEREST
ALL 5 Approval Studies:
- Same authors: Terrence P. Clark, Deborah D. Linton, Kevin J. Freise, Ting-Li Lin
- ALL paid Nexcyon Pharmaceuticals employees
Entire journal supplement paid for by manufacturer.
BOTTOM LINE
FDA approved Zorbium® based on:
- 343 cats total (Phase 2 + Phase 3)
- All healthy (excluded sick cats)
- All declawed (maximum pain)
- 96-hour observation (no long-term follow-up)
- Studies by manufacturer’s employees only
- No independent verification
- Coat color never tracked
- Non-validated pain scale
- Hyperthermia dismissed as “not meaningful”
- 19% failure rate called “effective”
Analysis by Zorbium® Information Center and AI
December 13, 2025