Repurposing Pharmaceuticals: “New” Drugs for Menopausal Symptoms

Low-fat mocha or chai tea latte? Caramel-cashew delight or plain vanilla?

Everyone likes choices. As a physician, I really like to have options in my toolkit. If one drug doesn’t work or causes unpleasant side effects, it’s nice to be able to offer my patients something else.

Recently, the FDA approved two new drugs for treatment of menopausal symptoms. Of course, they come with caveats, including questions on how truly effective they are, but I love having relatively safe options for my patients with unpleasant and sometimes difficult menopausal symptoms.

The ironic part is that both drugs are old friends in new packaging—one combines estrogen with a new non-hormonal compound; the other is an antidepressant that happens to be good at alleviating hot flashes.

The first, Duavee, was developed by Wyeth, a subsidiary of Pfizer, and came on the market last year. This drug takes a different approach to the traditional estrogen/progestin combo for women who still have their uterus. The estrogen part, Premarin in this case (called “conjugated estrogen”), eases the menopausal unpleasantness, while the progestin protects endometrial hyperplasia—the overgrowth of endometrial cells. (That’s why women who have undergone a hysterectomy can take estrogen-only drugs—they no longer have a uterus.)

Duavee replaces the progestin with bazedoxifene, a nonhormonal drug with the cumbersome classification of a selective estrogen receptor modulator or SERM. A SERM acts like estrogen in some tissues and it acts just the opposite in others, so bazedoxifene is also called an estrogen agonist/antagonist. It “selects” a tissue to either promote estrogen effects or block estrogen effects.

Yeah. Confusing. I know.

Here’s how Dr. Seibel, a well-known specialist in menopause and reproductive health, puts it, “The excitement about this medication is that bazedoxifene acts like a progestin, meaning it blocks the potential negative side effects of the Premarin [the estrogen component], but lets the Premarin continue to do its good stuff.”

The bazedoxifene component in Duavee does some other good stuff as well: It also protects against postmenopausal bone loss and “significantly increases bone mineral density,” according to Pharmacy Times.

So, according to the FDA, it can be prescribed for prevention of osteoporosis for at-risk women after other options without estrogen have been considered.

There are still risks to taking hormones, and the FDA still advises that, like any estrogen compound, Duavee be used at a low dosage for the shortest possible time for relief of menopausal symptoms.

For women who want to get away from hormones altogether, now there’s Brisdelle. Developed by Noven Therapeutics, Brisdelle is another old friend in new dress-up clothes—paroxetine, better known as Paxil. The “new” part is the very low dose.

Gynecologists have been aware for a while now that antidepressants can be helpful in relieving menopausal hot flashes, night sweats, and the sleeplessness associated with them. So sometimes we’ve prescribed antidepressants off-label.

The problem with that approach has been that the dosage for depression is higher than the dosage required for relief of menopausal symptoms (10 mg. rather than 7.5 mg.). The side-effects of that higher dosage can be weight gain and, god forbid, loss of libido. “The last thing a menopausal women needs is a drug that might sabotage her diet or an already waning sex drive,” says Dr. Streicher in this article.

Amen to that, sister.

With a dedicated drug like Brisdelle, you not only get the correct dosage to douse the flames of hot flashes, but you also avoid the confusion of being diagnosed with a completely different condition. A generic prescription for paroxetine would still be cheaper, but Brisdelle provides the right dosage for the right problem (hot flashes, not depression).

No drugs are perfect, but these two “new” drugs at least have a track record. They’re relatively safe and effective, and they add a couple of good options to the arsenal.

Nothing wrong with more choices, after all.

We Can Each Decide

In October, I traveled to Washington DC to participate in a public meeting and scientific workshop on female sexual dysfunction. The meetings came about because questions had been raised about whether the FDA was paying enough attention to women’s sexual health, and whether they’d set the bar higher for products for women than for comparable products for men (think Viagra or the 25 other prescription drugs for erectile dysfunction [ED]). ABC’s 20/20 found the meetings newsworthy enough to do a segment on the pursuit of “pink Viagra.”

I’m a pragmatic, Midwestern menopause care provider. I see women who are at all points of the spectrum from mild discomfort to despair. I make recommendations and write prescriptions for quite a range of options—from use of lubricants and vibrators to off-label testosterone. I certainly know that there’s no one-size-fits-all solution, no silver bullet, no magic pill that’s going to make every woman’s sexual experience legendary—or even comfortable.

As we’ve said before, women’s sexual desire, arousal, and response are complicated. Emotional security and intimacy, sexual history, and relationship satisfaction can make an already-complex reality even more difficult to untangle. Every woman deserves an individual approach. Every woman deserves a health care provider who can capably represent the options for treatment, when that’s needed—including describing the benefits and drawbacks. Every woman deserves to make her own choices to govern her quality of life—including her sex life.

So I watch with interest the discussion that’s transpired since the October meetings, reinforcing the messages I heard there. Sexual dysfunction is as real for women as for men. Yes, it’s true that some women find relief without pharmaceuticals. Yes, it’s true that there’s a profit motive for pharmaceutical companies. Yes, there’s a hazard in “medicalizing” women’s sexuality; we are not only biological systems. Yes, it often seems “pharma” is marketing out of control; I know I’ve seen enough ED commercials to last me the rest of my life.

And yet—if the FDA is charged with looking out for all of us, why wouldn’t that include women? And if they’re concerned with all health conditions, why wouldn’t that include sexual health? And if a pharmaceutical option is developed, and found by fair and rational standards to be both effective and healthful, why shouldn’t that option be made available to women who might choose to take advantage of it?

The FDA is accepting comments from the public—especially seeking insight from women who’ve suffered from sexual dysfunction—until December 29. You can read the questions in the FDA’s document online, and then submit your comments by clicking on the blue button at the right on this page on Regulations.gov.

Your story can help make clear what #WomenDeserve.

Think about What #WomenDeserve

This summer, in a blog post on the absence of pharmaceutical options for my treatment of women with hypoactive sexual desire disorder (HSDD), I said “I’m not in the room for the FDA discussions.” Thankfully, that’s about to change.

I’ve written here a number of times (as early as 2010 and as late as earlier this year) about the progress with the pursuit of “pink Viagra” and its frustrating setbacks. My message has consistently been that women’s sexuality is complicated, and no pill is going to fix everything for everyone.

But because of that very complication, as a physician, I value having options available. For one woman, simply thinking about intention and follow-through is enough to change the equation. For another, a combination of moisturizer, lubricant, and a powerful-enough vibrator is restorative. A third may require localized estrogen to rejuvenate tissues and restore comfort. You get the idea.

What that means is that the more options I have, the more likely I am to be able to work with a woman to maintain or restore the level of physical intimacy and sexual activity she wants. And I’m increasingly aware that while there are 26 drugs approved by the FDA for men’s erectile dysfunction, there is nothing that’s been approved for women facing comparable issues.

It’s not for want of trying. From the outside, it looks as though the bar is set higher for drugs for women than drugs for men. The side effects noted for drugs recently considered seemed more mild than that list we can all recite from hearing Viagra commercials since 1998. It doesn’t matter whether this is an intentional bias; what matters is that the FDA assure that it’s even-handed and supportive of women and their sexual health moving forward.

And that’s where the change comes in. Later this month, I’ll be traveling to Washington, DC, to attend a public hearing and then a workshop of women’s health experts, both intended to establish the reality of women’s experience (43 percent of us suffer from some sexual dysfunction!) and how the FDA can productively respond.

You can lend your voice to the proceedings. There’s a consortium of us who are concerned with women’s sexual health. We’re gathering signatures to a petition so that it’s clear to the FDA when we meet that this is a real problem, suffered by real women who seek a range of solutions. Add your voice at EvenTheScore.org or sign the #WomenDeserve petition at Change.org. Follow the discussion at the WomenDeserve Facebook community.

And I’ll keep you posted on the progress your voice has supported!