Osphena: Is the New Pill for Older Women Safe?

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Prepare yourself: When the new “pink Viagra” marketing blitz kicks off in June, instead of graying guys talking about sex between evening-news segments, you’re likely to see “mature” women.

The name of this new sex pill for postmenopausal women is Osphena, and while the market for it might not be as huge as Viagra’s is for men, the drug’s maker is banking that it will appeal to millions – especially after the company launches its “education” campaign about “dysparunia,” which Osphena is designed to treat.

But how many women really need Osphena, and how safe is it?

The Scoop on Osphena

For answers, we looked to Newsweek’s Daily Beast, which has done some serious homework on the new drug. Writing in the Beast, Jennifer Block reports that there’s more hype than help behind the drug’s claims, plus some scary risks and several unpleasant side effects. (Full disclosure: Block is a contributing editor for Senior Planet.)

In “Will This Pill fix Your Sex Life,” Block asks:

1. Is “dysparunia” a real disorder affecting a large percentage of women or just another example of “disease mongering,”like “female sexual dysfunction?
2. How was Osphena approved by the FDA in February 2013?  Who did those trials?
3. Is Osphena, which mimics estrogen, simply a ‘backdoor, off-label replacement for ‘hormone replacement therapy,’ with the same risks as HT?

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The HT Background

In case you stopped following the back-and-forth on the risks and (questionable) benefits of HT, here’s a recap, courtesy of Block (read her story for a close look at the influence wielded by the drug companies around HT):

• Back in the 60s, you may remember, drug companies started promoting the concept that menopause is a curable “estrogen deficiency.” Sales of estrogen-based hormone treatments skyrocketed.
• In 2002 the Women’s Health Initiative abruptly stopped a trial of HRT that was looking at its benefits. Not only were there no benefits, but the risks were high:  increased chances of breast cancer, coronary vascular disease, stroke and blood clots.
• The WHI findings remain controversial and drug companies would like to see them discredited, but several makers of women’s health policy have agreed on a global consensus statement: Menopause is not a disease, the statement says; and it doesn’t always need to be “treated” with hormones.

What Is Dysparunia?

Dyspareunia means pain before, during or after intercourse.  It’s for real and can occur for many reasons, from not enough foreplay to infection. Osphena targets Dysparunia that’s caused by vulvovaginal atrophy, a condition in which the skin of the vulva and the lining of the vagina become thin, dry and inflamed because of a lack of estrogen.  However, as Block points out, it’s kind of like gray hair and wrinkles: Most women have some of these changes as they age.  Like Female Sexual Dysfunction, she says, dyspareunia is an example of a new disorder designed to build a market for a drug.

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Back Door Estrogen

Osphena isn’t estrogen; it just acts like one, and like estrogen-alone therapy, Osphena increases the risk of endometrial cancer.  Stroke and deep vein thrombosis are also risks of taking the drug, albeit low ones compared to estrogen-alone therapy, says the FDA.  These risks are detailed in a prominent black box warning on the drug.

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Shortcomings of Osphena Trials

Block also points out that some experts have questions about the clinical trials that led to Osphena’s approval:

• Two 12-week trials were funded by the drug’s developers; the lead authors have strong ties to the companies. Not unusual for drug trials but not exactly an unbiased effort.
• The degree of improvement after 12 weeks was less than half a percent.  It “…sounds statistically significant…but how does that translate into something meaning to a person’s life?” one expert who reviewed the studies for Newsweek told Block.
• Benefit didn’t far outweigh harm, concluded another reviewer. Roughly 14 percent  of the study’s subjects improved(over placebo), but a similar percent had adverse effects, such as infection.

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The Multimillion-Dollar Questions

• Is the “down there” change after menopause as dire as “vulvovaginal atrophy” sounds?
• How many of the 32 million postmenopausal women who have it, have moderate or severe pain when having sex?
• How many for whom sex hurts can’t be helped with non-prescription remedies or safer, hormone creams?
• Is better sex worth the risk, if you have side effects?
• Ultimately, it’s a personal decision.  What would you do?

Block sees Osphena as the tip of an iceberg that may bring women testosterone gels and nasal sprays and antidepressants rebranded as libido enhancers. The big question she concludes with is, “…will these treatments bring more pleasure to women or to the pharmaceutical industry?”

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