Drug Treating Sexual Pain Among Postmenopausal Women Approved By FDA

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Main Category: Menopause
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals
Article Date: 27 Feb 2013 - 0:00 PST


The drug Osphena (ospemifene) has just been approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) that causes pain during sexual intercourse in postmenopausal women.

Dyspareunia occurs during menopause when estrogen levels drop to a level that causes vaginal atrophy, which is essentially the inflammation of the vagina due to shrinking and thinning of vaginal tissue. As a result, when women with vaginal atrophy engage in sexual intercourse it can be very painful and troublesome.

Approximately 32 million postmenopausal women in the United States suffer from VVA, with dyspareunia as one of the most commonly reported symptoms.

Opshena is very effective at alleviating the pain experienced during sex among such women, as an estrogen agonist it acts in the same way estrogen does on the vaginal tissues, making them thicker and less fragile.

Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said that the pill, which is taken with food once a day, will finally provide relief for postmenopausal women who suffer from dyspareunia.

The effectiveness of the drug was assessed in a series of three different clinical studies, which included a total of 1,889 women who all experienced symptoms of vulvar and vaginal atrophy. The participants were randomly assigned to take either Osphena or placebo.

Osphena - effective treatment but carries risks

Results from the first two trials revealed that, after twelve weeks of treatment, the women who took Osphena showed significant improvement, suffering far less from dyspareunia, compared to those who took the placebo. The results from the third trial identified the long-term safety of taking the drug.

The medication comes with a warning for patients and doctors, stating that it can stimulate the lining of the uterus, making it thicken.

Typically, a month before menstruation all fertile women experience stimulation and thickening of the uterus. However, it isn't normal for postmenopausal women, who no longer menstruate, to experience this stimulation and thickening.

As with estrogen-alone therapy, Osphena has been associated with an increased risk of endometrial cancer and thrombotic or hemorrhagic stroke.However, the risk of thrombotic or hemorrhagic stroke associated with taking Osphenia (0.72 and 1.45 per thousand women) is relatively low, when compared with estrogen therapy.

Because of the possible health risks associated with the medication, Osphena should only be prescribed for the shortest duration possible, consistent with treatment goals.

Some common side effects of the drug include:

• Vaginal discharge
• Muscle spasms
• Excessive sweating
• Genital discharge
• Hot flashes

Another FDA approved drug for postmenopausal women experiencing sex pain is PREMARIN Vaginal Cream, which was the first form of vaginal estrogen therapy approved for the treatment of moderate to severe dyspareunia.

Written by Joseph Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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