Osphena has been approved to treat dyspareunia, a condition caused by low estrogen levels during menopause that can make sex unbearable.
A multi-billion-dollar pharmaceutical juggernaut ensures that men have access to Viagra, Cialis, Levitra, and anything else they need to maintain a healthy sex life as they age.
But why should men have all the fun? For older women who experience sexual dysfunction, help is on the horizon.
The FDA has just approved a drug called Osphena to treat dyspareunia, a condition in which vaginal tissues become dry and fragile, making intercourse considerably painful.
Dyspareunia is typically caused by a drop in estrogen levels during menopause, but painful intercourse can also be triggered by inflammation, certain reproductive disorders, vaginal trauma, and psychological factors, including anxiety, depression, stress, and relationship woes.
It’s difficult to know how common dyspareunia is because it tends to go un-reported, but estimates are as high as 40 percent for women over 40. Osphena is the only drug on the market to treat this condition; until now, a woman’s only options were to invest in personal lubricant or to grin and bear it.
Osphena imitates the effect of the hormone estrogen on vaginal tissues, making them thicker and more durable. This means that menopausal and post-menopausal women can re-engage a key aspect of their lives.
“Expressing one’s sexuality is important at any age and that certainly goes for older women as well. We know that sex is good for us emotionally and physically, that there are concrete benefits to having sex, intimacy, touch, and connection with another,” said sexuality educator, counselor, and consultant Kelly J. Connell, M.S.Ed., C.A.S.H.E.
“With the baby boomers now turning 65 I think we will see a shift in the attitudes about openly discussing sex and seeking out solutions for sexual difficulties,” Connell added. “Sex is a quality of life issue, and seniors report it at the top of their list when it comes to things that are important to them.”
A word of caution: Osphena will carry a boxed warning on its label—the strongest warning the FDA can issue—due to the risk of deep vein thrombosis and other blood clots that can lead to stroke in some women. More common side effects include hot flashes, sweating, vaginal discharge, and muscle spasms.
Speaking of hot flashes, the good news for menopausal women continues to multiply. FDA staff reports reveal that two new non-hormonal drugs to treat hot flashes may soon be approved.
Sefelsa by Depomed Inc. and paroxetine mesylate capsules by the Japanese company Hisamitsu Pharmaceutical Inc. can be used to lessen the frequency and severity of hot flashes. According to Depomed, 13 million of the estimated 32 million menopausal women in the U.S. who experience hot flashes seek treatment.
The FDA will review studies of the two drugs at a meeting this Monday, and the agency will issue a final decision on the Sefelsa medication by May 31 and on the Hisamitsu drug by June 28.