Antidepressant Mirtazapine (Remeron®) Submitted For Approval In Japan

Main Category: Depression
Also Included In: Pharma Industry / Biotech Industry;  Psychology / Psychiatry
Article Date: 06 Jul 2007 - 1:00 PDT

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Organon, the human healthcare business unit of Akzo Nobel and Meiji Seika Kaisha has announced the filing of the new drug application for the novel antidepressant mirtazapine (also known as Remeron®) to the Japanese health authorities (PMDA).

Mirtazapine - a Noradrenergic and Specific Serotonergic Antidepressant (NaSSA) - has a different mechanism of action and has been proven safe and effective in the treatment of major depression in more than 80 countries worldwide. Nippon Organon and Meiji Seika Kaisha have been jointly developing mirtazapine tablets for depression since 2004. It has been available in other countries since 1994.

Mirtazapine has a fast onset of action and has been shown to be well tolerated. The Phase IIb trials in the Japanese population demonstrated efficacy of mirtazapine tablets over placebo. These results together with the earlier obtained results from a phase 3 trial (comparing mirtazapine with fluvoxamine in Japanese patients) show that mirtazapine tablets may be a first line option for the treatment of depression in Japan.

Depression is a common and seriously disabling mental disorder where patients experience depressed mood, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These symptoms can be chronic or recurrent and greatly reduce an individual's ability to take care of their everyday responsibilities. The lifetime incidence of depression in Japan is estimated to be 6.5%, indicating that about 7 million people suffer from depression. In the worst cases, depression can lead to suicide.

"Investigation of mental health issues and current status of its basis of measures in regional population in Japan"
Kawakami, N. et al.
In Research Report funded by MHLW, 2002.

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

http://www.organon.com