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每日1次曲唑酮制剂Oleptro获准用于治疗成人抑郁症

Once-daily trazadone product Oleptro approved for depression in adults

2010-02-09 【发表评论】
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ST LOUIS (MD Consult) - On February 3, 2010, Labopharm announced that the US Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) for the treatment of major depressive disorder (MDD) in adults. Oleptro is formulated as an extended-release tablet for once-daily administraton.

Support for the FDA approval of Oleptro was derived from results of a pivotal 8-week, randomized, double-blind, 2-arm, multicenter study of patients with unipolar MDD. The primary efficacy end point of the study was a comparison of the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the Oleptro group versus the placebo group. Statistical significance was achieved for the primary end point (P = .012).

The overall discontinuation rate in the study was 25% (21% in the placebo group and 30% in the Oleptro group). In the Oleptro group, 4% of patients discontinued treatment as a result of somnolence or sedation.

The most common adverse reactions associated with Oleptro are dizziness, constipation, blurred vision, and somnolence/sedation. The product label contains a black-box warning about the potential for an increased risk of suicidal thinking and behavior in children, adolescents, and young adults who are receiving antidepressants for major depressive disorder and other psychiatric disorders. Oleptro is not approved for use in pediatric patients.
 
Labopharm expects Oleptro to be available for prescription in the United States later in the year 2010.

圣路易斯(MD Consult)——201023日,Labopharm公司宣布,美国食品药品管理局(FDA)已批准Oleptro (盐酸曲唑酮)用于治疗成人抑郁症(MDD)Oleptro为缓释片剂,每日服用1次。

FDA批准Oleptro是基于对单相MDD患者进行的一项关键性研究的结果,该研究历时8周,为随机、双盲、2个亚组、多中心研究。其主要有效性终点为比较Oleptro治疗组与安慰剂对照组自基线起至研究结束时汉密尔顿抑郁量表(HAMD-17)总分的变化。主要终点达到统计学意义(P =0.012)

此研究的总中止率为25%(安慰剂对照组为21%Oleptro治疗组为30%)Oleptro治疗组有4%的患者因嗜睡或镇静而中止治疗。

Oleptro最常见的不良反应为头晕、便秘、视物模糊以及嗜睡/镇静。药品说明书中包含一黑框警告,指出儿童、青少年及青年人因重度抑郁症及其他精神疾病接受抗抑郁药治疗后,有出现自杀意念及行为的风险。Oleptro尚未获准用于治疗儿科患者。

Labopharm公司预计于2010年将Oleptro作为处方药推向美国市场。

Subjects:
mental_health
学科代码:
精神病学

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