Hisamitsu Pharmaceutical Co., Inc. Announces Notification of the Results of the Phase Iii Clinical Study of HP-3070 in the U.S
January 31, 2018 at 09:00 am
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Hisamitsu Pharmaceutical Co. Ltd. in conjunction with its U.S. subsidiary, Noven Pharmaceuticals, Inc. announced that the transdermal patch for the treatment of schizophrenia (Development code: HP-3070, generic name: asenapine maleate, hereinafter referred to as “the investigational product”) achieved the primary endpoint of the Phase III clinical trial in the U.S. This study was a Phase III clinical trial to evaluate the efficacy and safety of the investigational product in 617 patients diagnosed with schizophrenia. The primary endpoint of the study was change from baseline of the Positive and Negative Syndrome Scale (hereinafter “PANSS”) total score. Efficacy and safety was assessed during the six-week application period. The study results showed that when compared to placebo the investigational product achieved statistically significant improvement from baseline in the change of the total PANSS score at six weeks. Secondary endpoints are still under review. The systemic safety profile for the investigational product is consistent with that known for asenapine. The most common treatment-emergent adverse events observed in the clinical trial were application site reaction, headache and extrapyramidal disorder. Based on these study results, Hisamitsu Pharmaceutical will schedule a pre-New Drug Application (pre-NDA) meeting with FDA and expects to submit the NDA for the investigational product in the U.S. in Fiscal Year 2018. Additional details on the study results are planned for publication at future medical/scientific forums. The investigational product is a transdermal formulation developed using Hisamitsu’s Transdermal Drug Delivery System (TDDS) technology. Hisamitsu Pharmaceutical expects HP-3070 to be a promising new option in the treatment of schizophrenia.
Hisamitsu Pharmaceutical Co Inc is a Japan-based company mainly engaged in the pharmaceutical business. The Company is engaged in the manufacture, sale and supply of pharmaceuticals and related products, and the operation of over-the-counter drug (OTC) business. It is also engaged in the manufacture and sale of drugs in the United States, Brazil, Vietnam, and Indonesia, the development work in Europe, the drug marketing and sales in China and Hong Kong. It is also engaged in the urban cable television broadcasting business, Internet connection service business, non-life insurance agency business, advertising agency business and the purchase, manufacture and sale of packing materials.