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阿伐那非片(Stendra,AVANAFIL ,zepeed)(一)
2013-10-22 23:57:58 来源: 作者: 【 】 浏览:5641次 评论:0

2012年4月27日,美国食品药品管理局(FDA)和Vivus公司宣布,已批准Stendra(阿伐那非)用于治疗勃起功能障碍(ED)。Stendra是美国上市的商标名,zepeed是在韩国上市的是一种口服药物,在性行为之前约30 min时服用。每日服药不得超过1次。
Stendra是一种5型磷酸二酯酶(PDE5)抑制剂,与其他的PDE5抑制剂一样,正在服用硝酸盐类药物的男性不得使用Stendra,原因是这种联合用药可导致血压突然下降。
Stendra的安全性和有效性在3项双盲、安慰剂对照的临床试验中得到了验证。共有1,267例患者随机分组接受Stendra治疗,最长治疗时间为12周,剂量为50、100或200 mg,或服用安慰剂,均在性行为之前约30 min时按需服用。在各项研究开始时及此后每4周对患者进行1次问卷调查,以评估勃起功能、阴道插入和成功性交的情况。结果显示,服用3种剂量Stendra的患者在3个终点方面均获得了显著改善。
为了进一步评估Stendra的安全性,其中2项的部分受试者参加了另一项试验,接受至多达40周的额外治疗。最初采用100 mg剂量,此后可根据患者对治疗的应答情况将剂量增至200 mg或减至50 mg。结果显示,Stendra服用者报告的常见不良反应并未随服药时间延长而加重。
临床研究中患者报告的最常见(>2%)不良反应包括头痛、面部潮红、鼻充血、鼻咽炎和背痛。服用PDE5抑制剂(包括Stendra)的男性罕见突发视力下降或丧失。
Stendra可能与某些蛋白酶抑制剂、抗真菌药物和抗生素发生药物相互作用。Stendra不得与其他的ED治疗药物联用。
http://www.stendra.com/assets/pdf/STENDRA-avanafil-tablets-Patient-Information.pdf

 

MOUNTAIN VIEW, Calif., Sept. 18, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced the U.S. market availability of Qsymia™ (pronounced Kyoo sim ee' uh). Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). It is the first FDA-approved once daily combination therapy – and the first new medication available in 13 years – for the treatment of obesity.
VIVUS is formally introducing Qsymia to medical professionals this week at The Obesity Society's Annual Scientific Meeting in San Antonio, Texas.
"VIVUS is proud to be leading the way in the treatment of obesity, a disease with very serious health consequences," said Peter Tam, President of VIVUS. "Qsymia is the first ever combination treatment made available, and today's introduction marks a new beginning for many patients who struggle with obesity. We are excited about making this new treatment option available to patients because Qsymia is the first FDA-approved oral medication that has been shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification program."
To help ensure healthcare providers and patients are properly educated, VIVUS is emphasizing the Qsymia Risk eva luation and Mitigation Strategy (REMS) program, which includes a Medication Guide, healthcare provider training, patient brochure and other education tools. As part of the REMS program, Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network including CVS Pharmacy and Walgreens.
"The battle against obesity can seem hopeless, yet given the health consequences, it is absolutely critical that people who are at risk improve their weight," said Donna Ryan, M.D., associate executive director for clinical research at Pennington Biomedical Research Center in Baton Rouge, La., and former president of The Obesity Society. "It is time that healthcare professionals have a new medical treatment option allowing them to engage their patients who are in need, and start to turn the tide on this growing crisis."
"With the availability of this new therapeutic option, Americans struggling with o

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