Press Releases / Notices

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NEWS 2014

April 17, 2014 Pharmaceuticals

Nippon Shinyaku launches "Zalutia® tablets 2.5mg" and "Zalutia® tablets 5mg" for urinary disorder caused by benign prostatic hyperplasia

 Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan, President: Shigenobu Maekawa) today announced the launch of “Zalutia® tablets 2.5mg” and “Zalutia® tablets 5mg” (generic name: tadalafil) for urinary disorder caused by benign prostatic hyperplasia (BPH).

Zalutia® is a medication with a new mechanism of action (phosphodiesterase 5 inhibitor) for the treatment of urinary disorder caused by BPH developed by Eli Lilly Japan K.K. (Headquarters: Kobe, Japan; President: Patrik Jonsson). Eli Lilly Japan K.K. submitted a New Drug Application in February 2013 and received the marketing authorization in January 2014.
Urinary disorder caused by BPH is a condition which makes urination difficult mainly due to hyperplasia of prostatic cells (internal gland) that often occurs with aging. The disorder affects men 50 years of age or older and a variety of symptoms are observed such as “a weak stream when urinating”, ”difficulty empting the bladder” or “frequent urination during the day or night”.

This medication is expected to improve lower urinary tract symptoms of BPH through its phosphodiesterase 5 inhibiting effect, and is considered to improve blood flow by relaxing vascular smooth muscle, enhancing the relaxing activity of the urethra, prostate and bladder neck, and inhibiting the activity of afferent neurons in the bladder.
Urology is a priority area for Nippon Shinyaku, and through the launch of this medication, we hope to contribute to the improvement of patients’ QOL by providing the clinical settings with a new treatment option for urinary disorder caused by BPH.