Galderma公司于8月26日宣布,美国FDA批准其Mirvaso(brimonidine,溴莫尼定) 0.33%外用凝胶用于治疗18岁或以上的成年人酒渣鼻面部红斑(发红)。Mirvaso每日一次,奏效迅速减少酒渣鼻发红,持续时间长达12小时。 Galderma公司预计Mirvaso将于2013年9月在药房上架。
Louisville大学临床医学教授、Mirvaso III期研究首席研究员、皮肤科专家Mark Jackson指出:“面红是酒渣鼻最常见的症状是,但迄今没有治疗选择。FDA批准Mirvaso标志着酒渣鼻治疗的一个转折点:现在我们可为患者提供治疗酒渣鼻发红一种有效的药物。”
Mirvaso的获准基于两项为期一个月的III期临床研究550名患者的数据。这两项研究的结果表明,酒渣鼻成年人谁使用Mirvaso比空白的基质凝胶面红显著改善。此外,一项对276名患者的长期(12个月)尚在进行中。Mirvaso是外用凝胶,通过收缩扩张的面部血管产生作用,在面部五个区域(额头、下巴、鼻子和脸颊两侧)每日涂抹一次。
Mirvaso安全且耐受性良好。在对照临床试验中,最常见的不良反应(发生率≥1% )包括红斑、潮红、皮肤灼热感、接触性皮炎。在长期研究中,最常见的不良事件(≥ 4 %的受试者)包括潮红(10%)、红斑(8%) 、酒渣鼻(5%)、鼻咽炎(5%)、皮肤烧灼感(4%)、眼内压增加(4%)、头痛(4%)。
Mirvaso Topical Gel Approved for Facial Erythema of Rosacea
RELATED: Dermatological Disorders Resource Center
Mirvaso, an alpha-2 adrenergic agonist, is a first-in-class once daily topical gel that is believed to work by constricting the dilated facial blood vessels to reduce the redness of rosacea.
Approval of Mirvaso was based on data collected from more than 550 patients enrolled in two Phase 3 clinical studies of one-month duration. The results from both studies demonstrated that adults who used Mirvaso had a significantly greater improvement in the facial redness of rosacea than vehicle gel. The data showed that Mirvaso reduced redness for up to 12 hours. A long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted.
Mirvaso will be available as a 0.33% topical gel in pharmacies September 2013.