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.