LONASEN® Tablet/Powder is an oral antipsychotic agent created by Sumitomo Dainippon Pharma and was launched in Japan for the indication of schizophrenia in April 2008. In order to further stabilize the concentration of blonanserin in blood, Sumitomo Dainippon Pharma has been involved in a joint development since 2010 with Nitto who has the technology required for designing transdermal patch formulations, which led to submission of a new drug application on July 31, 2018.

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 check medication status and doses, visually. In addition, due to the profile of low food effects, this drug can administer to patients with irregular food take or with difficulty in swallowing.

This approval will allow Sumitomo Dainippon Pharma to provide patients affected by schizophrenia with a treatment option that has a novel administration route. This new option is expected to help promote shared decision-making (SDM: approach where patients and healthcare professionals make decisions of therapeutic strategy together), contribute to the improvement of adherence and treatment of schizophrenia targeting recovery of social function.

About LONASEN®

LONASEN® is an atypical antipsychotic agent with affinities for dopamine D2/D3 receptors and serotonin 5-HT2A 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. Sumitomo Dainippon Pharma currently sells LONASEN® Tablet/Powder and is preparing to launch its transdermal patch formulation.