Japan Approves World’s First Transdermal Beta-Blocker Patch

Toa Eiyo Ltd. has received manufacturing and marketing authorization in Japan for its transdermal Bisono® beta-blocker tape.

AsianScientist (Jul. 9, 2013) – Toa Eiyo Ltd. has received manufacturing and marketing authorization in Japan from the Japanese Ministry of Health, Labor and Welfare for its Bisono® tape 4mg and Bisono® tape 8mg.

The tape, the world’s first transdermal β1-blocker patch, was originally developed by Nitto Denko in collaboration with Toa Eiyo. It will be manufactured by Nitto Denko, marketed by Toa Eiyo, distributed and sold by Astellas Pharma Inc., and promoted by both Toa Eiyo and Astellas.

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.

Bisono® tape is a transdermal patch for the treatment of hypertension containing 4mg or 8mg of bisoprolol with β₁-blocking activity, administered once a day for 24 hours applied to the chest, upper arm or back.

In Phase III clinical studies, the Bisono® tape demonstrated a stable antihypertensive effect for 24 hours with once-a-day administration 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.

According to the company, the transdermal formulation will provide patients who have difficulties with oral drugs an alternative method of delivery, which may contribute to improving patient adherence. A visual reminder of treatment may also reduce the risk of missed or excessive dosage, says the company.

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Source: Nitto Denko Corporation.
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