FDA to review Otsuka and Lundbeck's potential schizophrenia game changer
- The FDA is reviewing a New Drug Application (NDA) for Otsuka and Lundbeck's brexpiprazole as a first-line treatment for schizophrenia and a secondary therapy for major depression.
- The NDA is based on seven phase II and III studies encompassing more than 6,000 participants and 5,000 patients who received treatment.
- Brexpiprazole showed promise in improving schizophrenia symptoms, as measured by the Positive and Negative Syndrome Scale (PANSS), compared to placebo. It had more tempered results on depression patients.
If approved, this could be a game changer for Otsuka, whose popular antipsychotic Abilify (aripiprazole) saw $1.03 million in sales in Q1 2014 -- a slide from previous quarters. Brexpiprazole could be a natural successor in the company's mental health portfolio, especially considering that schizophrenia affects about 2.4 million American adults.
“We and our collaborator Lundbeck are proud to have reached this juncture in the development of brexpiprazole," said William Carson, president of Otsuka pharmaceutical development. "In view of the importance of good mental health and the projected impacts of mental health disorders on people affected, their families and society, future new treatment options will be indispensable."
- Pharmafile FDA accepts new schizophrenia drug filing