The US FDA Approves Vanda Pharmaceuticals' Fanapt for Treating Bipolar I Disorder
Shots:
- The US FDA has granted approval to the company’s Fanapt (iloperidone) tablets as an acute treatment for manic or mixed episodes associated with bipolar I disorder in adults
- The approval was supported by the pivotal study carried out in patients (n=400) with adults with manic or mixed episodes associated with bipolar I disorder. The 1EP of the study was evaluated using the Young Mania Rating Scale of clinical severity in the core symptoms of mania
- The study at wk.4 demonstrated improvement with Fanapt vs PBO and a significant benefit was observed during wk.2 on YMRS evaluation at the end of wks. 1, 2, 3 and 4. The safety profile was consistent with that of the previous schizophrenia studies
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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.
