Lurasidone HCl, marketed as Latuda, has received approval from the Food and Drug Administration for the treatment of schizophrenia in adolescents aged 13-17 years old, according to a press release from Sunovion Pharmaceuticals.
FDA批准鲁拉西酮是基于一项为期6周的研究结果。在该研究中，青少年精神分裂症患者每日服用鲁拉西酮40 mg、80 mg或安慰剂。与安慰剂组相比，盐酸鲁拉西酮组患者精神分裂症症状呈现具有统计学意义的临床改善。鲁拉西酮耐受性良好，无重大不良事件报告。
FDA approval of Latuda is based on results of a 6-week study in which adolescents with schizophrenia received either 40 mg of lurasidone per day, 80 mg per day, or a placebo. Patients who received lurasidone HCI showed statistical and clinical improvements in schizophrenia symptoms, compared with the placebo group. The drug was well tolerated with no significant adverse events reported.
Lurasidone HCl previously has been approved to treat schizophrenia in adults, as well as for treatment of major depressive episodes in adults with bipolar disorder I, either alone or as adjunctive therapy with lithium or valproate.
试验研究员、约翰霍普金斯大学儿童与青少年精神病学主任Robert L. Findling博士在新闻稿中指出：对青少年精神分裂症发展及不良预后的影响，凸显了对良好耐受性和有效性治疗药物的需求。鲁拉西酮上市为医护人员治疗此慢性、严重失能性青少年疾病提供了重要的新选择。Findling博士也是巴尔的摩Kennedy Krieger研究所负责精神病服务与研究的副所长。
“The impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well tolerated and effective,” Robert L. Findling, MD, study investigator, and director of child and adolescent psychiatry at Johns Hopkins University, Baltimore, said in the press release. “The availability of Latuda provides health care providers with an important new option for helping adolescents with this illness that is chronic and severely disabling,” said Dr. Findling, also vice president of psychiatric services and research at the Kennedy Krieger Institute, Baltimore.
Find the full press release on the Sunovion Pharmaceuticals.
来源： Frontline Medical News