Sumitomo Pharma and Otsuka Failed to Meet its Primary Endpoints of Ulotaront in P-III Trials (DIAMOND 1 & 2) for Schizophrenia
Shots:
- The P-III trials evaluating ulotaront (qd) vs PBO in 435 & 464 acutely psychotic adults with schizophrenia
- The trials did not meet their 1EPs & showed a reduction in PANSS total score over time in patients treated with ulotaront (50 & 75 mg/day) in the (DIAMOND 1) trial while ulotaront (75 & 100mg/day) showed numerically larger mean reductions in PANSS total score from baseline at 6wk. in the (DIAMOND 2) study
- Both studies' results were not superior to PBO & did not show significant improvement over PBO (LS mean in both studies: -16.9 & -19.6 in ulotaront (50 & 75mg/day) and -16.4 & -18.1 in (75 & 100mg/day) vs -19.3 & -14.3 in PBO, a large PBO effect was observed resulting in the molecule's therapeutic effect
Ref: Otsuka | Image: Otsuka
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