Toa Eiyo Obtains Marketing Authorization for Bisono® tape in Japan
World’s First Transdermal β₁-Blocker Patch Developed to Contribute to Treatment of Hypertention Patients
Nitto Denko Corporation (“Nitto Denko”; Head Office: Osaka, Japan; President and CEO: Yukio Nagira) announced today that Toa Eiyo Ltd. (“Toa Eiyo”; Head Office: Tokyo, Japan; President: Hidemi Konno) has received manufacturing and marketing authorization in Japan from the Japanese Ministry of Health, Labour and Welfare for “Bisono® tape 4mg” and “Bisono® tape 8mg” which had been successfully developed by Nitto Denko in collaboration with Toa Eiyo as the world’s first transdermal β1-blocker* patch. Bisono® tape is to be manufactured by Nitto Denko, marketed by Toa Eiyo, distributed and sold by Astellas Pharma Inc. (“Astellas”; Tokyo, Japan; President and CEO: Yoshihiko Hatanaka), and promoted by both Toa Eiyo and Astellas.
Background of Development
Nitto Denko has developed the technology for designing transdermal patch systems for various kinds of drugs to be absorbed through the skin into the body. Approximately forty million people suffer from hypertension in Japan. Hypertension is caused by a wide variety of factors, thus patients are recommended a choice of antihypertensive medication either alone or in combination. Nitto Denko expects that Bisono® tape, with its unique transdermal formulation, will offer a novel choice of hypertension medication for patients having difficulties with oral administration (including dysphagia) and contribute to improving patient adherence.
Features of Bisono® tape
Bisono® tape is a transdermal patch for the treatment of hypertension containing 4mg or 8mg of bisoprolol with β₁-blocking activity, which is administered once a day for 24 hours applied to the chest, upper arm or back.
The features of Bisono® tape are as follows:
Maintains stable antihypertensive effect for 24 hours with once-a-day administration
Can be administered to patients with essential hypertension having difficulties taking oral drugs
Visual reminder of treatment can be expected to improve patient adherence by reducing a risk of missed or excessive dosage.
In Phase III studies, Bisono® tape demonstrated sufficient continuous antihypertensive effects over a period of 24 hours in Japanese patients suffering from mild to moderate essential hypertension. The frequencies of side effects of Bisono® tape were similar to those of other oral β₁–blockers except those on the administration site.
*: β₁-blockers are a group of drugs that can selectively block β₁-receptors of the adrenergic receptors in the sympathetic nervous system, typically expressed on heart and kidney. β₁-blockers cause demonstrate antihypertensive effect by decreasing cardiac output, suppressing norepinephrine release from the sympathetic nerve terminals and/or suppressing renin release from the juxtaglomerular cells.