Hisamitsu and Noven Pharma declares transdermal patch for Schizophrenia

Hisamitsu Pharmaceutical in collaboration with U.S subsidiary, Novel Pharmaceuticals, Inc declares that the 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.

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 changed from baseline of the Positive and Negative Syndrome Scale (hereinafter “PANSS”) total score. Efficacy and safety was assessed during the six-week application period. Study results marked 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.