The US Food and Drug Administration has cleared the use of Lundbeck and Otsuka Pharmaceutical's antipsychotic Rexulti for the treatment of both schizophrenia and major depressive order.
The drug’s approval for schizophrenia, which affects around 2.4 million adults in the US, came on the back of data showing statistically significant efficacy for improving symptoms (as shown by Positive and Negative Syndrome Scale) versus placebo.
Clinical trials also showed that Rexulti (brexpiprazole) improved symptoms compared to placebo when used as an adjunctive therapy in patients with MDD, which is estimated to affect some 15 million patients, many of whom are failing to respond adequately to monotherapy with antidepressants.
Rexulti, which is dosed once daily with or without food, is due to hit US pharmacy shelves in early August.
According to Thomson Reuters Cortellis, analysts are expecting the drug to pull in annual sales of $1.4 billion by 2020, Reuters reports.