Sumitomo Dainippon Reports Results of Lurasidone Hydrochloride (lurasidone) in P-III JEWEL Study in Patients with Schizophrenia
Shots:
- The P-III JEWEL Study involves assessing lurasidone (40 mg/day) vs PBO @6wks. in 483 patients with Schizophrenia- conducted for regulatory approval in Japan
- The P-III JEWEL Study results demonstrated the patients treated with Lurasidone responded positively; PANSS (Positive and Negative Syndrome Scale) score (-19.3 vs -12.7); AE (47.0% vs 51.1%); patients discontinued treatment (19.4% vs 25.4%); patients discontinued treatment due to AE (5.7% vs 6.4%); well-tolerated
- Lurasidone is an atypical antipsychotic candidate indicated to treat Schizophrenia and is approved in multiple countries including the US & EU in 2010 & 2014 respectively. In H1’19- Sumitomo plans to file NDA for Lurasidone in Japan- for schizophrenia & bipolar depression
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