AbbVie’s Vraylar (cariprazine) Receives the US FDA’s Approval as an Adjunctive Treatment for Major Depressive Disorder
Shots:
- The US FDA has approved Vraylar as an adjunctive therapy to antidepressants for MDD. The therapy is being jointly developed by AbbVie & Gedeon Richter Plc
- The P-III study (3111-301-001) & (RGH-MD-75) evaluating cariprazine + ADT vs PBO + ADT in a ratio (1:1:1) in patients with MDD. The dose can be increased to 3mg, qd on Day 15 based on clinical response & tolerability
- Both studies showed a significant change from baseline to 6 & 8wk. in MADRS total score for patients with cariprazine (1.5mg/day & 2-4.5mg/day) + ADT over PBO + ADT, was well tolerated & mean weight change was <2lbs & ≤3% had a weight increase of ≥7%. Vraylar is 1st dopamine & serotonin partial agonist & the US FDA- approved for MDD & depressive episodes associated with bipolar I disorder
Ref: Globenewswire | Image: uniQure
Related news :- AbbVie’s Vraylar (cariprazine) Receives the US FDA’s Approval as an Adjunctive Treatment for Major Depressive Disorder
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