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近日，美国FDA批准其新药Imvexxy（estradiol vaginal inserts 中文名：雌二醇阴道插入物），用于治疗中度至重度性交疼痛（与性活动有关的阴道疼痛），这是由于绝经引起的外阴和阴道萎缩（VVA）症状。值得一提的是，Imvexxy是其治疗类别中唯一一款可提供4微克和10微克剂量的产品，4微克是目前可用阴道雌二醇的最低批准剂量。
VVA是绝经期泌尿生殖系统综合征（GSM）的一部分，生殖器症状有干燥、灼烧和刺激，性症状有润滑减少、不适和疼痛，泌尿系统症状有尿急、排尿困难和反复发作的尿路感染。VVA是一种慢性进行性病症，会引起不适症状，如不及时治疗情况会逐渐恶化。VVA影响了美国约3200万绝经后女性，她们中仅有7％（230万）的人在接受处方治疗。有81%的女性不知道VVA是一种可治疗的疾病，她们还有医疗需求未被满足。
由TherapeuticsMD带来的Imvexxy可以将阴道内和周围组织重新雌激素化（re-estrogenization ）。它独特的配方能确保药物完全溶解，因此患者可以在一天中的任何时间使用它。Imvexxy通常需要每天使用持续2周，之后可以每周使用2次。参与临床试验的10名患者中有9名报告说，该药物“易于使用”。
此次Imvexxy获得FDA批准是基于一项随机、双盲、安慰剂对照3期研究的结果。该研究评估了Imvexxy（4微克和10微克）与安慰剂相比从基线到第12周的疗效和安全性。研究表明，两种剂量的Imvexxy在第2周时就已经能够缓解由于绝经而导致的中度至重度性交疼痛。REJOICE试验的一个亚组还评估了Imvexxy（4微克和10微克）和安慰剂的药代动力学。结果显示，在两种剂量下，雌二醇和雌酮的平均浓度仍在平均绝经后范围内。安全性方面，在治疗组和安慰剂组之间没有观察到有显著临床差异的不良事件（AE）。
“Imvexxy是一种生物相同的阴道雌激素产品，可以提供市场上许多现有产品的平均雌激素剂量的一小部分，”TherapeuticsMD首席临床官Brian Bernick博士表示：“Imvexxy是唯一一款专门设计成无涂抹器的产品。它能完全溶解，不会造成混乱，或需要进行额外清洁，并且患者可以在一天中的任何时候使用它。它让女性可以迅速恢复正常的日常活动。研究表明，在使用Imvexxy的患者中，雌二醇的全身吸收保持在绝经后的范围内。”
“我们很高兴能够将Imvexxy推向市场，它是TherapeuticsMD首个获得FDA批准的药物，而我们也正努力成为优秀的女性健康公司，”TherapeuticsMD首席执行官Robert Finizio先生表示：“Imvexxy体现了我们长期以来的企业使命和致力于解决女性健康需求的承诺，这些都是基于医疗需求、疗效、安全性、简便性和可负担性。Imvexxy将以与其它已上市10到30年的产品相同的价格提供，以确保患者能够以合理的价格获得Imvexxy。通过这些，TherapeuticsMD正在为女性做正确的事情。”
IMVEXXY™(estradiol vaginal inserts)
IMVEXXY Rx
Generic Name and Formulations:
Estradiol 4mcg, 10mcg; vaginal inserts.
Company:
TherapeuticsMD, Inc.
Indications for IMVEXXY:
Moderate-to-severe dyspareunia due to menopause.
Adult:
Use lowest effective dose for the shortest duration. Initially one 4mcg insert intravaginally once daily for 2 weeks, then 1 insert twice weekly every 3–4 days. Reevaluate periodically.
Children:
Not established.
Contraindications:
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer or estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Hepatic impairment or disease. Known anaphylactic reaction or angioedema.
Boxed Warning:
Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.
Warnings/Precautions:
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically.
Pharmacological Class:
Estrogen.
Interactions:
May be antagonized by CYP3A4 inducers (eg, St. John's wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Adverse Reactions:
Headache; thromboembolism, neoplasms.
Generic Availability:
NO
How Supplied:
Vaginal inserts—8, 18
http://www.imvexxy.com/hcp/
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