Alfresa Pharma and Mitsubishi Tanabe Pharma : Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment

November 25, 2011 - Alfresa Holdings Corporation (head office: Tokyo, Representative Director & President: Denroku Ishiguro) and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, President & CEO: Michihiro Tsuchiya) announced that Alfresa Pharma Corporation (head office: Osaka, President & CEO: Kenichiro Iwaya), a subsidiary of Alfresa Holdings engaged in manufacture of pharmaceuticals etc., received approval of a partial change in the indications of MODIODAL® Tablets 100 mg (generic name: modafinil), a sleep disorder treatment, that has been jointly developed in Japan by Alfresa Pharma and Mitsubishi Tanabe Pharma.

Since March 2007, MODIODAL® has been jointly marketed by the two companies as a treatment for excessive daytime sleepiness associated with narcolepsy, a sleep disorder characterized by intolerable daytime sleepiness. The new indication, approved for the first time in Japan, is “excessive diurnal sleepiness accompanied with obstructive sleep apnea syndrome (OSAS) under treatment for airway obstruction by continuous positive airway pressure (CPAP) therapy and the like”. The two companies expect MODIODAL® will contribute to improve quality of life of patients whose daily lives would otherwise be disrupted by excessive diurnal sleepiness in OSAS as well as narcolepsy.

MODIODAL® is currently approved in more than 30 countries in the world, and in seven countries, including the US, it is marketed with approval for the new indication... [PDF] Alfresa's Press Release - [PDF] Mitsubishi Tanabe Pharma's Press Release -