2013年1月24日讯 /生物谷BIOON/ --辉瑞（Pfizer）今天宣布，PRISTIQ缓释片在一项IV期研究中达到了主要终点。该项研究支持了50mg/天及100mg/天剂量的PRISTIQ相对于安慰剂在超过8周的治疗期间对严重抑郁症成人患者的疗效。
英文原文：
Pfizer Inc. (PFE: Quote) said that a Phase 4 study assessing the efficacy of PRISTIQ Extended Release Tablets met its primary endpoint. The study supports the efficacy of 50 mg/day and 100 mg/day doses of PRISTIQ compared with placebo over eight weeks of treatment in adult patients with major depressive disorder or MDD as measured by the 17-item Hamilton Rating Scale for Depression or HAM-D17 total score.1
In this trial, the most common treatment-emergent adverse events observed were consistent with the known safety and tolerability profile of PRISTIQ.
The Phase 4 study, whose primary efficacy endpoint was the change from baseline in HAM-D17 total score at week eight, was designed as a multi-center, randomized, double-blind, placebo-controlled, eight-week, parallel group study in adult patients with MDD. The HAM-D17 is a validated assessment tool used to rate the severity of a patient's major depressive symptoms.
PRISTIQ Phase 4 trial results would be submitted for presentation at upcoming scientific congresses and for publication in a peer-reviewed medical journal.
