Teva Reports Encouraging Data From Late-Stage Schizophrenia Trial

Teva Pharmaceuticals Industries Ltd TEVA announced results from the Phase 3 trial comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo for schizophrenia patients who underwent stabilization on oral risperidone.
Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24, and demonstrated a significant increase in proportions maintaining stability.
The most common adverse reactions were nasopharyngitis, increased weight, and extrapyramidal disorder.
Time to impending relapse significantly favored TV-46000 with overall: 0.283; q1m: 0.200 and q2m: 0.375 versus placebo.
TV-46000 also prolonged the time to relapse by 3.5, 5.0, and 2.7 times, respectively, versus placebo.
Proportions of patients with impending relapse at week 24 were significantly lower for TV‑46000 (overall: 9%; q1m: 7%; q2m: 11%) versus placebo (28%).
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