| Product name (INN)/ Development code |
Bisono® Tape (Bisoprolol) |
|---|---|
| Formulation and Strength |
Transdermal patch 2 mg, 4 mg and 8 mg |
| Indications | Hypertension Atrial fibrillation Chronic heart failure (Under development) |
| Territories available for out-licensing |
Any country (excl. Japan) |
| Development phase | Launched in Japan as a treatment for hypertension in 2013 Approved in Japan as a treatment for atrial fibrillation in 2019 Phase II in Japan as a treatment for chronic heart failure |
| Origin | In-house |
| Product description | Bisono®Tape (previous development code: TY-0201), a transdermal patch formulation of bisoprolol, was launched as a treatment for hypertension in Japan in 2013, as the first transdermal patch of a beta-1 blocker in the world, followed by an approval for the new treatment of atrial fibrillation in 2019. Bisono®Tape can sustain a blood plasma concentration more steadily than oral formulations, and maintain stable blood pressure and heart rate lowering effects for 24 hours with once-per-day administration. It can be expected to provide a new choice for hypertension or atrial fibrillation treatment for patients who cannot take oral medications (i.e., with dysphagia or in the perioperative period), and has the advantage of serving as a visual reminder of administration for both patients and caregivers, leading to improved drug adherence. Clinical trials are underway for the additional indication of chronic heart failure. |
| Results of clinical trials |
As a Phase III clinical trial for hypertensive patients, an 8-week randomized, double-blind, placebo-controlled study was conducted to evaluate the superiority of TY-0201 8 mg to placebo and the non-inferiority of TY-0201 8 mg to the oral formulation of bisoprolol fumarate (BO) 5 mg. The changes in diastolic blood pressure from baseline following treatment in the TY-0201 8 mg, BO 5 mg, and placebo groups were -12.2 mm Hg, -11.8 mm Hg, and -3.7 mm Hg, respectively, with TY-0201 8 mg demonstrating superiority to placebo and non-inferiority to BO 5 mg. As a Phase III clinical trial for persistent or permanent atrial fibrillation patients, a 4-week randomized, double-blind, comparative study was conducted to evaluate the non-inferiority of TY-0201 to BO. Adjusted means of changes in 24-h mean heart rate (mHR) from baseline in the TY-0201 4 mg, TY-0201 8 mg, BO 2.5 mg, and BO 5 mg groups were -12.3, -13.8, -12.7, and -14.3bpm, respectively. TY-0201 had heart rate-reducing effects similar to those of BO. The incidence of adverse events did not differ between the groups. |
| Related news / Key publications |
1. Matsuoka H, Kuwajima I, Shimada K, Mitamura H, Saruta T. Comparison of efficacy and safety between bisoprolol transdermal patch (TY-0201) and bisoprolol fumarate oral formulation in Japanese patients with grade I or II essential hypertension: randomized, double-blind, placebo-controlled study. Journal of Clinical Hypertension. 2013 Nov;15(11):806-14.
2. Momomura SI, Saito Y, Yasumura Y, Yamamoto K, Sakata Y, Daimon M, et al. Efficacy and Safety of Switching From Oral Bisoprolol to Transdermal Patch in Japanese Patients With Chronic Heart Failure.
Circulation Journal: Official Journal of the Japanese Circulation Society. 2017 Dec 25;82(1):141-7.
3. Yamashita T, Ikeda T, Akita Y. Comparison of heart rate reduction effect and safety between bisoprolol transdermal patch and bisoprolol fumarate oral formulation in Japanese patients with persistent/permanent atrial fibrillation (BISONO-AF study). J Cardiol. 2018 Dec 24.
|