FDA批准Osphena治疗女性性交疼痛

圣路易斯(MD Consult)——2013年2月26日，美国食品药品管理局(FDA)宣布批准盐野义制药公司的口服药物Osphena(ospemifene)用于治疗女性绝经期外阴和阴道萎缩引起的中至重度性交疼痛。Osphena是具有组织选择效应的雌激素受体激动剂/拮抗剂，可代替阴道或口服甾体雌激素。

3项临床研究在1889例有外阴和阴道萎缩症状的绝经后女性中确立了Osphena的安全性和有效性。患者随机接受Osphena或安慰剂治疗。治疗12周后，前2项研究的结果显示，Osphena组女性性交疼痛的改善比安慰剂组显著。第3项研究结果支持Osphena长期治疗性交疼痛的安全性。

临床研究显示，与安慰剂组相比，Osphena 60 mg每日1次组的最常见不良事件包括潮热(7.5% vs 2.6%)、阴道分泌物(3.8% vs 0.3%)、肌肉痉挛(3.2% vs 0.9%)、多汗(1.6% vs 0.6%)和外阴分泌物(1.3% vs 0.1%)。

Osphena的黑框警告指出，由于无对抗雌激素的作用，使用Osphena可刺激子宫内膜，进而增加子宫内膜癌发生的风险。子宫内膜增生是子宫内膜癌先兆，在雌激素治疗基础上加用孕激素可降低子宫内膜增生的风险。黑框警告还提醒，接受单纯雌激素治疗的女性有发生深静脉血栓形成和卒中的风险。

接受Osphena治疗的女性在出现异常阴道出血时应就诊。应根据每个女性的治疗目标与风险给予最短期的Osphena。

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ST LOUIS (MD Consult) - On February 26, 2013, the US Food and Drug Administration (FDA) and Shionogi announced the approval of Osphena (ospemifene), an oral treatment for women experiencing moderate to severe dyspareunia related to vulvar and vaginal atrophy that can occur in association with menopause. Osphena acts as an estrogen agonist/antagonist with tissue-selective effects and is a treatment alternative to vaginal or oral steroidal estrogen.

Osphena's safety and effectiveness were established in 3 clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Patients were randomly assigned to receive either Osphena or a placebo. After 12 weeks of treatment, results from the first 2 trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women who received placebo. Results from the third study support Osphena's long-term safety in treating dyspareunia.

In clinical studies, the most commonly reported adverse reactions in patients treated with Osphena 60 mg once daily compared with patients who received placebo included hot flashes (7.5% vs 2.6%), vaginal discharge (3.8% vs 0.3%), muscle spasms (3.2% vs 0.9%), hyperhidrosis (1.6% vs 0.6%), and genital discharge (1.3% vs 0.1%).

Osphena is being approved with a Boxed Warning. The use of Osphena can stimulate the endometrium, thus increasing the risk of endometrial cancer because of the effects of unopposed estrogen. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. The Boxed Warning also warns of the risk of deep vein thrombosis and stroke in women who receive estrogen-alone therapies.

Women for whom Osphena is prescribed should be advised to seek evaluation for unusual vaginal bleeding. Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for an individual woman.