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 详细处方信息以本药内容附件PDF文件（2017122623545639.pdf）的“原文Priscribing Information”为准
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部分中文米那普伦处方资料（仅供参考）

米那普伦(milnacipran Hcl，Savella)治疗纤维肌痛综合征有效
    Forest与Cypress宣布美国FDA已批准米那普伦盐酸盐(milnacipran Hcl，Savella)用于治疗纤维肌痛。纤维肌痛是一种以全身性疼痛与疲劳为主的疾病。根据美国风湿病学会估计大约有6百万美国人患有纤维肌痛。

　　虽然对于本品改善纤维肌痛症状的确切机制尚不明确，但一些研究者认为：某些脑部神经递质的异常可能是纤维肌痛的关键所在。本品可能是通过对5-羟色胺与去甲肾上腺素(NE)再摄取的双重抑制(在体外对NE再摄取抑制的选择性更强)来改善纤维肌痛症状。

　　在美国进行的2项关键性III期临床研究中，共纳入2084例患者，其中1460例患者接受本品治疗，624例患者则使用安慰剂。结果显示：与安慰剂相比，本品(剂量为100mg/天、200mg/天)能同时显著改善疼痛(视觉模拟评分)、患者整体评价(患者对变化的整体印象评分)与生理功能 (Short Form-36 总体生理健康)。预期，本品将于2009年3月上市。

　　本品的安全性与耐受性良好。最常见的不良反应为恶心。其他常见不良反应包括便秘、潮热、多汗、呕吐、心悸、心率上升、口干与高血压。本品所报道的大多数不良反应为轻微至中等程度。

Savella (milnacipran hydrochloride)
Company: Forest Laboratories
Approval Status: Approved January 2009
Treatment for: fibromyalgia
Areas: Musculoskeletal

General Information
Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor. It affects the two neurotransmittersalmost equally (a 3:1 norepinephrine to serotonin balance). However, the exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown.

Savella is specifically indicated for the management of fibromyalgia in adults.

Savella is supplied as a tablet designed for oral administration. The recommended initial dose of the drug is 100 mg/day (50 mg twice daily). Dosing should be titrated according to the following schedule:
Day 1: 12.5 mg once Days 2-3: 25 mg/day (12.5 mg twice daily) Days 4-7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)

Doses above 200 mg/day have not been studied.

Clinical Results
FDA Approval
FDA approval of Savella was based on the results of two clinical trials.

Study One
This 6-month double-blind, placebo-controlled, multicenter study enrolled adult patients (18-74 years of age). The subjects received daily doses of Savella 100 mg and 200 mg or placebo. The minimum mean baseline pain score of >50 mm on a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst possible pain). The mean baseline pain score in this trial was 69. More patients in the Savella treatment arms experienced at least a 30% reduction in pain from baseline (VAS) and considered themselves globally improved (PGIC) than did patients in the placebo arm.

Study Two
This 3-month, double-blind, placebo-controlled, multicenter study enrolled adult patients (18-74 years of age). The subjects received daily doses of Savella 100 mg and 200 mg or placebo. The minimum mean baseline pain score was >40 mm on a 100- mm VAS ranging from 0 (no pain) to 100 (worst possible pain). The mean baseline pain score in this trial was 65. improvement. More patients in the Savella treatment arms experienced at least a 30% reduction in pain from baseline (VAS) and considered themselves globally improved (PGIC) than did patients in the placebo arm.

In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment.

Ongoing Study Commitments
Forest Labs has agreed to a deferred pediatric study under PREA for the management of fibromyalgia in pediatric patients ages 13 through 17.
Protocol Submission: July 2009
Study Start Date: January 2010
Final Report Submission: October 2014
Forest Labs has agreed to develop and maintain a prospective, observational pregnancy exposure registry study conducted in the United States that compares the pregnancy and fetal outcomes of women exposed to Savella (milnacipran HCl) during pregnancy to an unexposed control population. The registry will detect and record major and minor congenital anomalies, spontaneous abortions, stillbirths, elective terminations, and any serious adverse pregnancy outcomes. These events will be assessed among the enrolled women throughout the pregnancy. The events will also be assessed among infants through at least the first year of life. Annual interim reports will be submitted until FDA has acknowledged that sufficient data have been collected.
Protocol Submission: July 2009
Study Start Date: January 2010
Final Report Submission: Within six months of FDA notification that sufficient data have been collected.
Forest Labs has agreed to a single-dose, pharmacokinetic, open-label, clinical trial in healthy, lactating women. Concentrations of Savella (Milnacipran HCl) will be assessed in maternal plasma and breast mild so as to estimate potential infant exposure.
Protocol Submission: August 2009
Trial Start Date: August 2010
Final Report Submission: February 2012

Side Effects
Adverse events associated with the use of Savella may include, but are not limited to, the following:
Nausea
Headache
Constipation
Hot flush
Hyperhidrosis
Vomiting
Palpitations
Heart rate increased
Dry mouth
Hypertension

Mechanism of Action
Savella (milnacipran) is a selective serotonin and norepinephrine reuptake inhibitor. It affects the two neurotransmittersalmost equally (a 3:1 norepinephrine to serotonin balance). However, the exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown.

Additional Information
For additional information regarding Savella or fibromyalgia, please visit the Savella web page.

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 详细处方信息以本药内容附件PDF文件（2017122623545639.pdf）的“原文Priscribing Information”为准
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