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Sumitomo Pharma and Otsuka Failed to Meet its Primary Endpoints of Ulotaront in P-III Trials (DIAMOND 1 & 2) for Schizophrenia

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Sumitomo Pharma and Otsuka Failed to Meet its Primary Endpoints of Ulotaront in P-III Trials (DIAMOND 1 & 2) for Schizophrenia

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  • 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

Related News:- Otsuka and Lundbeck Receive the US FDA’s Approval for Rexulti (brexpiprazole) sNDA to Treat Agitation Associated with Dementia Due to Alzheimer’s Disease

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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