ST LOUIS (MD Consult) - On January 18, 2011, ParaPRO announced that the US Food and Drug Administration (FDA) has approved Natroba (spinosad) topical suspension 0.9%, a prescription treatment for the eradication of head lice (pediculosis capitis) in persons aged 4 years and older. According to ParaPRO, one application of Natroba resolves most head lice infestations in about 10 minutes, and no nit-combing is required.
In 2 phase 3 clinical studies, treatment with Natroba was significantly more effective in eliminating head lice than treatment with permethrin 1% (marketed under the brand name NixR), which was the head-lice treatment recommended by the American Academy of Pediatrics at the time the study protocol was approved by the FDA. The 1,038 participants with active head-lice infestations were provided with either Natroba or NixR to be used at home. A total of 84.6% (study 1) and 86.7% (study 2) of Natroba-treated participants were assessed to be lice-free 14 days after the last treatment, compared with 44.9% and 42.9% treated with permethrin (P < .001 for both studies). Most participants in the Natroba groups (63.8% and 86.2%) needed only 1 product application, whereas most participants in the permethrin groups (60.3% and 64.5%) required 2 product applications.
The most common adverse events reported in the clinical studies by patients assigned to either product included redness or irritation of the eyes and skin.
The safety of Natroba used in pediatric patients younger than 4 years has not been established. The FDA warns that it is especially important not to use Natroba on infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.
圣路易斯(MD Consult)——2011年1月18日，ParaPRO公司宣布，美国食品药品管理局(FDA)已经批准0.9%的Natroba(多杀菌素)外用混悬剂用于根除年龄≥4岁患者的头虱。据ParaPRO公司称，这种处方药可在大约10 min内祛除大部分头虱，而且无需用篦子刮除虱卵。
2项Ⅲ期临床试验显示，Natroba在祛除头虱方面的疗效显著优于1%的氯菊酯(商标为NixR)，后者在本研究方案获FDA批准的同时被美国儿科学会推荐用于治疗头虱病。在这2项试验中，1,038例活动期头虱感染者在家中使用Natroba或NixR进行治疗。结果显示，Natroba组患者中共有84.6%(研究1)和86.7%(研究2)在末次治疗后14天未发现头虱，而上述比例在氯菊酯组患者中分别为44.9%和42.9%( P值均小于0.001)。Natroba组多数患者 (63.8%和86.2%)仅需要使用1次Natroba，而氯菊酯组多数患者(60.3%和64.5%)需要使用2次氯菊酯。
两组患者报告的最常见不良事件包括眼睛和皮肤发红或刺激。
目前尚未确定4岁以下儿童使用Natroba的安全性。FDA警告称，由于Natroba含有苯甲醇，故尤其应注意勿对婴儿应用此制剂。将苯甲醇外用于6个月龄以下婴儿的皮肤，可导致死亡等严重的不良反应。
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