Yamanouchi Pharma America submits NDA for YM905 to treat overactive bladder
PARAMUS, N.J., Jan. 9, 2003 -- Yamanouchi Pharma America, a subsidiary of Japan's Yamanouchi Pharmaceutical Co., Ltd., announced that it has filed a New Drug Application (NDA) with the FDA for YM905 (solifenacin succinate), an investigational muscarinic antagonist that acts on the receptors in the smooth muscle of the bladder.
The application contains clinical data from four multi-centered, randomized, double-blinded, placebo- controlled efficacy studies conducted in the United States and Europe to support the use of YM905 for the relief of symptoms of urinary frequency, urinary incontinence or urgency associated with overactive bladder.
"The filing of this NDA application with the FDA is an important milestone for the company because YM905 was discovered and developed by Yamanouchi and will be the first product independently marketed by the company in the United States," said Akihiko Matsubara, President and Chief Operating Officer of Yamanouchi Pharma America, Inc. "We look forward to working with the FDA on this important application while we continue to grow as a fully integrated U.S. pharmaceutical company and strive to become a leader in the field of urology."
In the United States, more than 16 percent of men and women aged 40 or older are reported to experience symptoms of overactive bladder. The number of potential patients is estimated to be about 20 million, but only 20 percent are being treated currently.
Source: Yamanouchi Pharma America www.yamanouchiamerica.com
Posted: January 2003
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