10月28日美国FDA批准盐酸鲁拉西酮(lurasidone HCI)每日一次片剂用于精神分裂症患者一线治疗,其商品名为Latuda。鲁拉西酮是日本Dainippon Sumitomo制药公司开发一种非典型抗精神病药物。

鲁拉西酮的疗效在4项为期6周的安慰剂对照试验得到证实。在这些研究中,鲁拉西酮在主要疗效指标方面相对安慰剂显示明显大的改善,其中包括在研究终结时阳性和阴性症状量表(PANSS)总分和简明精神病评定量表(从PANSS量表衍生)。共有5项试验证实了鲁拉西酮的耐受性和安全性。

鲁拉西酮短期临床研究中报告的与之相关的常见不良反应有嗜睡、静坐不能、恶心、帕金森氏症样症状和情绪激动。

The FDA has approved Latuda (lurasidone HCl tablets, from Sunovion), an oral once-daily atypical antipsychotic, for the treatment of schizophrenia in adults. This approval was based on four six-week controlled studies which demonstrated that Latuda (lurasidone HCl tablets) has significantly greater improvement compared to placebo on the primary efficacy measures [the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study endpoint.

Latuda is expected to be available during the first quarter of 2011 in 40mg and 80mg dosage strengths.