FDA批准Jazz公司生产的羟丁酸钠口服液（sodium oxybate，Xyrem）用于治疗嗜睡症患者的白天睡眠过多(EDS)。

　　本项批准基于1项为期4～8周的4中心随机双盲安慰剂对照的临床研究的结果。研究结果显示，嗜睡症患者晚上服用本品可减少白天睡眠过多及猝倒。

　　嗜睡症是1种慢性神经性疾病，主要症状是白天睡眠过多、夜晚无法连续睡眠及猝倒。美国有超过15万的嗜睡症患者，但只有不到5万的患者会求助医生。FDA于2002年7月批准本品用于治疗嗜睡症患者的猝倒。

      新药羟丁酸钠(Sodium Oxybate)的临床实验数据，这些数据在两项后期临床实验中获得，药物在临床期间表现良好。

　　实验结果表明，患者用药后，可显著缓解疼痛和疲倦，并改善日常生活能力。目前，该药已经以Xyrem作为商品名销售，适应症为发作性睡病。

　　上述后期临床实验为期14周，共有573名纤维肌痛综合征患者参加。与安慰剂相比较，在疼痛缓解方面，羟丁酸钠的效果更为显著，缓解率相对高出30%;在身体机能和日常行为能力的改善方面，受试组效果也优于安慰剂对照组。此外，该药还能明显缓解患者疲倦症状。

　　在用药期间，最常见的副作用为头晕、呕吐、失眠、焦虑、嗜睡、疲倦、肌肉痉挛和外周水肿。但Jazz/UCB表示，这种药物的耐受性良好，多数不良反应比较轻微。

　　UCB相关负责人称，药物在上述III期临床实验中的表现都较为理想，为它通过销售批准奠定了基础，这令人鼓舞，同时也预示着一种新型疗法即将产生。

Once-A-Day LUVOX CR^® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Important Safety Information

CONTRAINDICATIONS

The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.

ADVERSE EVENTS

In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.