Pfizer Announces DUAVEE® (conjugated estrogens/bazedoxifene), an Estrogen-Based Menopause Hormone Therapy, Now Back in Stock with Improved Packaging

NEW YORK, June 5, 2023 – Pfizer Inc. (NYSE: PFE) today announced that DUAVEE® (conjugated estrogens/bazedoxifene), an estrogen-based menopause hormone therapy, is now back in stock in the United States, with improved packaging, following a voluntary recall. The recall was due to an issue with the packaging and was not based on any efficacy or safety concerns with the product itself.

Duavee was approved by the U.S. Food and Drug Administration (FDA) in October 2013 for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause and the prevention of postmenopausal osteoporosis. In May 2020, Pfizer issued a global voluntary recall of Duavee to implement packaging updates to ensure product stability throughout its shelf life. Following the completion of packaging updates and regulatory filing, Duavee is now available in the United States, and will be made available in additional markets as local regulatory filings/reviews are completed.

The North American Menopause Society recommends either a combination of estrogens and progestin or a tissue selective estrogen complex (TSEC) for those considering hormone therapy for the management of moderate to severe hot flashes in postmenopausal women with a uterus. Duavee is the only TSEC to pair conjugated estrogens with bazedoxifene – an estrogen agonist/antagonist – instead of a progestin.  The bazedoxifene component reduces the risk of the uterine lining thickening that can occur with the conjugated estrogens component.

“Many of my patients have been anxiously awaiting the return of Duavee, and I’m pleased to be able to offer this progestin-free menopause hormone therapy for postmenopausal women with a uterus,” said Risa Kagan, MD, FACOG, CCD, NCMP, Clinical Professor, Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco and Sutter East Bay Medical Group. “Millions of women in menopause suffer from hot flashes, which can be debilitating. Treatment guidelines strongly support menopause hormone therapy for appropriate women experiencing vasomotor symptoms yet only about 30 percent seek treatment^i,ii.”

It is estimated that 50 million women have reached menopause in the United States and up to 85 percent experience symptoms like hot flashesⁱⁱⁱ. Many are also at risk of osteoporosis. Duavee has been shown to help reduce moderate to severe hot flashes due to menopause and increase bone mineral density.  The most common adverse reactions (≥ 5 percent) in clinical trials were muscle spasms, nausea, diarrhea, upset stomach, abdominal pain upper, throat pain, dizziness, and neck pain^iv.

About DUAVEE (conjugated estrogens/bazedoxifene)

Estrogens have been used as hormonal treatments for over 70 years to help manage menopausal symptoms. Using estrogen alone can increase the chance of developing cancer of the uterine lining. When treating postmenopausal women with a uterus, estrogens have traditionally been combined with a progestin. This can decrease the risk of hyperplasia (the thickening of the endometrium), which may be a precursor to cancer of the uterine lining.

Duavee is the first and only therapy to pair conjugated estrogens (CE) with an estrogen agonist/antagonist also known as a selective estrogen receptor modulator (SERM). DUAVEE uses bazedoxifene - instead of a progestin - to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment.

Duavee should not be used in women who: have or had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or had certain cancers (e.g., uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant or are breastfeeding a baby.

DUAVEE INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

Duavee is used after menopause for women with a uterus to reduce moderate to severe hot flashes and to help reduce the chances of developing osteoporosis (thin, weak bones).

If you use Duavee only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

Duavee should be taken for the shortest time possible and only for as long as treatment is needed. You and your healthcare provider should talk regularly about whether you still need treatment with Duavee. Please see full Prescribing Information, including BOXED WARNING and Patient Information.
Patients should always ask their doctors for medical advice about adverse events.

IMPORTANT SAFETY INFORMATION

Do not take progestins, additional estrogens, or additional estrogen agonists/antagonists while taking Duavee® (conjugated estrogens/bazedoxifene).

Using estrogen alone may increase your chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while taking Duavee. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. A healthcare provider should check unusual vaginal bleeding to find the cause.

Do not use estrogens to prevent heart disease, heart attacks, strokes, or dementia.

Estrogen alone may increase the chance of getting blood clots or strokes.

Using estrogen alone may increase the chance of getting dementia, based on a study of women 65 years of age or older.

The risks listed above are based on a study of an estrogen-alone oral product. Since other products and doses have not been studied in the same way, it is not known how the use of Duavee will affect your chances of getting these conditions.

Estrogens should be used at the lowest dose possible, only for as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Duavee.

Do not use Duavee if you: have or had blood clots; are allergic to estrogens or bazedoxifene, the active ingredients of Duavee; have unusual vaginal bleeding; have or had certain cancers (e.g., uterine or breast), liver problems, or bleeding disorders; or are pregnant.

If you take thyroid medication, consult your healthcare provider, as use of estrogens may change the amount needed.

Serious side effects include blood clots, stroke, heart attack, cancer of the lining of the uterus, breast cancer, cancer of the ovary, dementia, gallbladder problems, loss of vision, high blood pressure, increased fats in your blood, liver problems, thyroid problems, fluid retention, low calcium, swelling of your mouth or tongue, worsening of other medical problems such as asthma, diabetes, epilepsy, migraines, a genetic problem called porphyria, lupus and liver problems.

Call your healthcare provider right away if you have any of the following warning signs, or any other unusual symptoms that concern you: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Less serious, but common side effects include: muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness, neck pain.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

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Disclosure Notice
The information contained in this release is as of June 5, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about DUAVEE (conjugated estrogens/bazedoxifene), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in particular jurisdictions for DUAVEE for any potential indications; whether and when regulatory authorities may approve any such applications for DUAVEE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether DUAVEE will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of DUAVEE; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

ⁱ Pinkerton JV. N Engl J Med. 2020;382(5):446-55.
ⁱⁱ Kagan R, et al. Drugs Aging. 2019;36:897-908.
ⁱⁱⁱ McKinlay SM, et al. Maturitas. 1992;14(2):103–15.
^iv Duavee. Prescribing information. Pfizer; 2022.