The FDA has approved an estradiol softgel vaginal insert (Imvexxy – TherapeuticsMD) for treatment of postmenopausal women with moderate to severe dyspareunia due to vulvovaginal atrophy (VVA). Imvexxy is the second estradiol vaginal insert to be approved in the US; Vagifem, an intravaginal tablet formulation, was the first. Vagifem and Imvexxy are both available in inserts containing 10 mcg of estradiol; Imvexxy is also available in a 4-mcg strength.

Sexual complaints related to desire, arousal, orgasm and painful intercourse are common in women. Since the last Medical Letter article on this subject, some new information has become available.

Three low-dose transdermal estrogens were recently approved by the FDA for treatment of menopausal vasomotor symptoms. Elestrin and Divigel are transdermal estradiol gels and Evamist is an estradiol spray. Elestrin has been marketed in Europe since 1976.

The FDA has approved elagolix (Orilissa – AbbVie), an oral gonadotropin-releasing hormone (GnRH) antagonist, for management of moderate to severe pain associated with endometriosis.

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...

Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.

Three new combination oral contraceptives (COCs) with shortened hormone-free intervals, Seasonique, Loestrin 24 Fe and Yaz, have recently been approved by the FDA. All 3 are derivatives of older products.

The FDA has approved over-the-counter (OTC) sales of Plan B (Duramed), an emergency contraceptive package that contains two 0.75-mg tablets of levonorgestrel, to women ≥18 years old. Younger women still require a prescription. In one trial, two levonorgestrel 0.75-mg tablets taken 12 hours apart, the first within 72 hours after unprotected intercourse, decreased the pregnancy rate to 1%, compared to an expected rate of 8% (Task Force on Postovulatory Methods of Fertility Regulation, Lancet 1998; 352:428). How high doses of a progestin taken after coitus prevent pregnancy is unclear; they may...

Seasonale (Barr), the first "extended-cycle" oral contraceptive, is now available in the US for pregnancy prevention. Active tablets containing 30 ╡g of ethinyl estradiol and 0.15 mg of levonorgestrel are taken for 84 consecutive days, followed by 7 days of inactive tablets, allowing for withdrawal bleeding only four times a year. Other combination oral contraceptives are dispensed as 21 days of active tablets and 7 days of placebo or no tablets, resulting in 13 withdrawal bleeding episodes each year.

The FDA has approved lanadelumab-flyo (Takhzyro – Takeda), a subcutaneously-administered plasma kallikrein inhibitor, for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. Lanadelumab is the third drug to be approved for this indication; the human plasmaderived C1 esterase inhibitors (C1INHs) Cinryze, which is administered IV, and Haegarda, which is given SC, have been available for years for HAE prophylaxis in patients ≥6 years old.