Solution for painful intercourse

“Imvexxy” approved for painful female intercourse

A possible new solution for painful female intercourse may be just what many women have been waiting for. Imvexxy, a prescription vaginal insert, could help postmenopausal women who experience sexual pain.

The drug was approved by the U.S. Food and Drug Administration in May.

Painful intercourse is a common problem for post-menopausal women. The hormone estrogen keeps vaginal tissue flexible and lubricated. When estrogen levels drop at menopause, the vagina can become brittle and dry, making sex uncomfortable.

Starting this month, post-menopausal women could have a new treatment option for painful intercourse.

In May 2018, the U.S. Food and Drug Administration (FDA) approved Imvexxy, an estradiol vaginal insert for women with moderate-to-severe sexual pain. According to a press statement, TherapeuticsMD, the drug’s manufacturer, expects Imvexxy to be available in September.

Sexual pain is a common problem after menopause, when a woman’s estrogen levels drop considerably. Estrogen is important for keeping vaginal tissue healthy and flexible. When levels decline, the vagina can shorten and narrow, with the walls becoming dry and brittle. Women may find that their vagina is less lubricated during sex. Together, these symptoms can lead to uncomfortable friction, tearing, and bleeding during vaginal intercourse.

The medical term for this situation is vaginal and vulvar atrophy (VVA). An estimated 50% of postmenopausal women experience it to some degree. Unfortunately, VVA does not improve on its own.

“Studies have shown that many women are not seeking treatment for VVA and 81% are unaware that VVA is a treatable medical condition and part of a constellation of symptoms associated with loss of estrogens,” said Dr. Sheryl Kingsberg, President of the North American Menopause Society, in the press release.

Imvexxy works by bringing a dose of estradiol, a type of estrogen, directly to the vagina. (Doses may be 4 micrograms or 10 micrograms.) According to TherapeuticsMD, women insert one capsule daily for the first two weeks of treatment, then continue doing so just once a week. The capsule dissolves in the vagina.

In trials of Imvexxy, some women saw improvements in sexual pain in about two weeks. The most common side effect was headache.

The FDA requires that Imvexxy labels carry a “black box” warning, which alerts consumers to serious risks, including endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.

TherapeuticsMD will be conducting a post-approval observational study as instructed by the FDA.

Resources

FDA.gov

“A Guide to Drug Safety Terms at FDA”

(November 2012)

https://www.fda.gov/downloads/forconsumers/consumerupdates/ucm107976.pdf

Medscape Medical News

Brown, Troy, RN

“FDA Approves Imvexxy for Moderate to Severe Dyspareunia”

(May 31, 2018)

https://www.medscape.com/viewarticle/897436?nlid=122810_3901&src=wnl_newsalrt_180531_MSCPEDIT&uac=137928SK&impID=1646633&faf=1

Reuters