Print（PDF/81KB） Sep. 03, 2019 Products

Sumitomo Dainippon Pharma to Launch Atypical Antipsychotic LONASEN Tape in Japan

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced the launch of a transdermal patch formulation of atypical antipsychotic LONASEN^® Tape 20 mg, 30 mg, and 40 mg (generic name: blonanserin, hereinafter, “this Drug”) in Japan on September 10, 2019.

This Drug is the world’s first transdermal patch formulation approved for the indication of schizophrenia.

Blonanserin is a compound created by Sumitomo Dainippon Pharma and exerts antagonistic effects against dopamine D₂ / D₃ receptors and serotonin 5-HT_2A receptors. In clinical studies, it showed efficacy for both the positive symptoms (such as hallucinations or delusions) and negative symptoms (such as blunted affect or avolition) of schizophrenia. Since April 2008, Sumitomo Dainippon Pharma has marketed LONASEN^® Tablet/Powder, an oral agent whose active ingredient is blonanserin, in Japan.

In order to further stabilize the concentration of blonanserin in blood, since 2010 Sumitomo Dainippon Pharma has been involved in the joint development of this Drug with Nitto Denko Corporation, who has the technology required for designing transdermal patch formulations, which led to the approval of its new drug application on June 18, 2019.

This Drug is expected to be well-tolerated and efficacious, because once-daily application of this Drug to the skin maintains a stable drug concentration in blood for 24 hours. This Drug also has the beneficial characteristics of patch formulations, namely, it is easy to visually check medication status and doses. In addition, due to the minimal effect of food on its pharmacokinetics, this Drug can be administered to patients who have irregular food intake or difficulty swallowing.

With the launch of this Drug, Sumitomo Dainippon Pharma will provide a new treatment option of a “patch” administration route to schizophrenia patients. This new option is expected to help promote shared decision-making (SDM: an approach where patients and healthcare professionals make decisions on therapeutic strategy together), thus contributing to the improvement of adherence and treatment of schizophrenia targeting recovery of social function.