Food and Drug Administration (FDA) in the US accepted the applying of Brexpiprazole, a newly dopamine serotonin partial agonist developed by Otsuka Pharmaceutical collaborated with Lundbeck in Denmark, for clinical indication.
According to the reports, the indicative diseases are schizophrenia and depression (adjunctive therapy). FDA will complete the process of examination in the next July.
Lundbeck: US FDA accepts Otsuka and Lundbeck's filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression
Drugs.com: FDA Accepts Filing for Review of Brexpiprazole
Otsuka pharmaceutical is one of leading companies in Japan in the drug industry. It has an advantage especially in psychiatric region. Aripiprazole, the first dopamine partial agonist, has won several prize for its innovative effects. In my opinion, Aripiprazole is highly recommendable for patients suffering from schizophrenia or treatment-resistant depression.
Brexpiprazole is so called a successor to Aripiprazole. I was involved in a clinical trial to evaluate its efficacy and safety. I cannot describe the result due to confidentiality. More or less, it is desirable for patients to gain another therapeutic option.
On the other hand, I think that Otsuka had to hasten the development of Brexpiprazole, because the patent of Aripiprazole will be negated in 2015. After that, several companies will begin to sell generic medicines of Aripiprazole with low cost. It will undoubtedly reduce the profit of Otsuka. Thus, leading companies such as Otsuka have to invent new products constantly for sustainable growth.
My past entry: Trial in India about patent of a new drug
This landscape is not limited in the medical industry, as I wrote recently. IT industry is also chaotic. Yet, developing a new drug takes astronomical cost. There are few chances for small companies to overcome. Rather, some drug companies are forced to be combined with competitors in order to stabilize financial situation.
My past entry: Samsung shift its strategy in smartphone
As a medical practitioner, I appreciate the efforts of all drug companies. There are many patients waiting for more effective medicines.