Transdermal patch for treatment of schizophrenia hits Phase III goals

Japanese drugmaker Hisamitsu Pharmaceuticals (TYO: 4530), along with US subsidiary Noven Pharmaceuticals, say their transdermal patch for the treatment of schizophrenia (HP-3070, generic name: asenapine maleate) has achieved the primary endpoint of the Phase III clinical trial in the USA.

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 (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.