Nippon Organon submits mirtazapine

Organon, the human health care business unit of Dutch drugs and chemicals firm Akzo Nobel, says it will file a New Drug Application for its novel antidepressant mirtazapine (known as Remeron in most countries) with Japanese regulators towards the middle of 2007, three years earlier than expected.

"This is very exciting news for us," said Emile van Dongen, executive vice president, global sales. "The Japanese market is an important market and we are confident that mirtazapine's fast onset of action and tolerability will make it a first-line option for depression in Japan," he said.

The noradrenergic and selective serotonergic antidepressant (NaSSA) has been available in other countries since 1994. According to Organon, it has a unique mechanism of action and has been proven safe and effective in the treatment of major depression in many countries. Organon's Japanese unit has been developing mirtazapine for depression in partnership with Meiji Seika Kaisha since 2004.