BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia
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- The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies
- The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety & tolerability of Cobenfy for over 1yr.
- Studies reached the 1EPs, showing reduced schizophrenia symptoms with 9.6 (-21.2 vs -11.6 in EMERGENT-2) and 8.4 (-20.6 vs -12.2 in EMERGENT-3) point reductions in PANSS total scores at wk.5. EMERGENT-2 study also depicted a change of 0.6 (-1.2 vs -0.7) in CGI-S score at wk.5 (2EP)
Ref: BMS | Image: BMS
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
