ST LOUIS (MD Consult) - On November 2, 2010, Cadence Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Ofirmev (acetaminophen), an intravenously (IV)administered analgesic and antipyretic for the management of mild-to-moderate pain, the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever in hospitalized adults and children.
The FDA approval of Ofirmev was granted on the basis of data from clinical trials in which a total of 1020 adult and 355 pediatric patients received IV acetaminophen. These trials included 2 studies evaluating the safety and effectiveness of Ofirmev for the treatment of pain, and one study evaluating Ofirmev for the treatment of fever. In a study of 101 patients undergoing hip or knee replacement surgery, treatment with Ofirmev 1000 mg given every 6 hours was statistically superior to the use of placebo for the reduction of pain intensity over 24 hours (P < .01) with significantly reduced morphine consumption (33% over 24 hours, P < .01). In a second study of 244 patients undergoing abdominal laparoscopic surgery, patients receiving treatment with Ofirmev 1000 mg every 6 hours or 650 mg every 4 hours demonstrated a significant reduction in pain intensity over 24 hours compared with patients given placebo (P < .02).
In a study of adult volunteers with induced fever, participants given a single dose of Ofirmev 1000 mg demonstrated a statistically significant reduction in temperature through 6 hours compared with participants given placebo (P < .01), with an onset of action within 15 minutes after treatment.
The safety and effectiveness of Ofirmev for the treatment of pain and fever in pediatric patients older than 2 years is supported by evidence from well-controlled studies in adults as well as additional safety and pharmacokinetic data for this pediatric age group. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients younger than 2 years.
Ofirmev was well tolerated in clinical trials assessing safety in a range of patient and surgery types. The most common adverse reactions in patients treated with Ofirmev were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. The antipyretic effects of Ofirmev may mask fever in patients treated for postoperative pain.
Ofirmev should be administered only as a 15-minute IV infusion. The maximum recommended daily dose of acetaminophen should not be exceeded. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. The use of Ofirmev is contraindicated in patients with severe hepatic impairment, severe active liver disease, or with known hypersensitivity to acetaminophen.
圣路易斯(MD Consult)——2010年11月2日，Cadence Pharmaceuticals公司宣布，美国食品药品管理局(FDA)已批准Ofirmev(静脉注射用对乙酰氨基酚)用于治疗轻、中度疼痛，辅以阿片类止痛药用于治疗中、重度疼痛，以及用作住院的成人和儿童患者的退热药。
FDA根据相关临床试验的数据批准了Ofirmev，这些试验总共纳入1,020例成人患者和355例儿科患者，他们均接受了对乙酰氨基酚静脉注射用药。其中有2项研究对Ofirmev治疗疼痛的安全性和疗效进行了评估，有1项对Ofirmev治疗发热的疗效进行了评估。在一项对101例行髋关节或膝关节置换术的患者进行的研究中，采用Ofirmev治疗(1,000 mg/ 6 h，持续24 h)的退热效果显著优于安慰剂对照(P <0.01)，并可显著减少吗啡的用药量(24 h内减少33%，P<0.01)。在另一项对244例行腹腔镜手术的患者进行的研究中，接受Ofirmev (1000 mg/6 h或650 mg/4 h，持续24 h)治疗的患者疼痛程度较安慰剂对照组显著减轻(P <0.02)。
在一项对诱导性发热的成人志愿者所做的研究中，接受Ofirmev1,000 mg单剂治疗的受试者在6 h内体温相对于安慰剂对照组显著降低(P <0.01)，并在用药后15 min内即可起效。
对2岁以上的儿科患者采用Ofirmev治疗疼痛和发热的安全性和疗效有相关的证据支持，其中包括对成人进行的有良好对照的研究以及由该年龄段小儿科患者获得的其他安全性和药代动力学数据。Ofirmev治疗急性疼痛和发热的疗效尚未在2岁以下的小儿科患者中进行探讨。
在对一系列患者和手术类型所做的安全性评估临床试验中，Ofirmev的耐受性良好。在接受Ofirmev治疗的成人患者中最常见的不良反应为恶心、呕吐、头痛和失眠，而在小儿科患者中为恶心、呕吐、便秘、瘙痒、烦躁不安以及肺不张。Ofirmev的退热效应可能会掩盖接受术后疼痛治疗者的发热现象。
Ofirmev的静脉注射时间应为15 min，不得超过其最大推荐日剂量用药。超过推荐剂量应用对乙酰氨基酚时可能会引起肝损伤，其中包括重度肝中毒和死亡的风险。Ofirmev禁用于有重度肝损害、重度活动性肝病或已知对对乙酰氨基酚过敏的患者。
