林业发展局核准Caplyta为抗抑郁剂反应不力的抑郁症附加治疗。 FDA approves Caplyta as add-on treatment for depression unresponsive to antidepressants.

食品及药物管理局(FDA)批准对患有严重抑郁症的成年人(Caplyta)采取附加治疗措施, The FDA has approved lumateperone (Caplyta) as an add-on treatment for adults with major depressive disorder who haven’t responded to antidepressants. 根据两个第3阶段的试验,在抗抑郁剂中每天增加42毫克的Caplyta剂量,导致症状显著改善,与安慰剂相比,反应和缓解率更高。 Based on two phase 3 trials, adding 42 mg daily of Caplyta to antidepressants led to significant symptom improvement, with greater response and remission rates compared to placebo. 该药物显示出一种有利的安全特征,其重量增加、新陈代谢问题或运动紊乱的风险最小。 The drug showed a favorable safety profile, with minimal risk of weight gain, metabolic issues, or movement disorders. 长期数据显示,65%的病人在六个月内获得缓解。 Long-term data showed 65% of patients achieved remission at six months. 对于精神分裂症和两极抑郁症,这是Caplyta的第四个迹象。 Approved for schizophrenia and bipolar depression, this is Caplyta’s fourth indication.