Otsuka and Lundbeck file application for schizophrenia and depression drug
- Otsuka and Lundbeck have submitted a new drug application (NDA) to FDA for brexpriprazole, which was developed for the treatment of schizophrenia and as co-therapy in the treatment of major depressive disorder (MDD).
- The NDA is supported by seven phase II/phase III trials.
- Full-scale review is expected in September.
The clinical development program for brexpripazole, a serotonin-dopamine activity modulator, included over 6,500 subjects. Otsuka developed brexpriprazole in 2011 and later entered into a co-development and co-commercialization agreement with Lundbeck.
Recently, Lundbeck and Takeda launched Brintellix (vortioxetine), a multimodal antidepressant that performed exceptionally well in clinical trials and has the potential to become a blockbuster drug. In May, BioPharma Dive reported on the dearth of new treatment options for MDD. Lundbeck’s commitment to development in this therapeutic area is laudable.
The brexpriprazole development team may pursue additional uses for the medication, including anxiety disorders, dementia, post-traumatic stress disorder, sleep disorders and ADHD.
- Pharmaceutical Business Review Otsuka, Lundbeck file NDA for brexpiprazole to treat schizophrenia and MDD
- marketwatch.com Brexpiprazole (Major Depressive Disorder) - Forecast and Market Analysis to 2023