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Pfizer Inc. Announces FDA Approval Of DUAVEE™ (conjugated Estrogens/ Bazedoxifene) For The Treatment Of Moderate-to-Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause And The Prevention Of Postmenopausal Osteoporosis [1]

Pfizer Inc. (NYSE:PFE), a leader in the development of treatments for menopausal symptoms, is pleased to announce that the United States Food and Drug Administration (FDA) has approved DUAVEE TM (conjugated estrogens/bazedoxifene) 0.45mg / 20mg tablets, a novel therapy for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis [1]. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk and non-estrogen medication should be carefully considered [1]. DUAVEE is a once daily tablet taken orally. It is recommended that all menopausal hormone therapies, including DUAVEE, be used for the shortest duration consistent with treatment goals and risks for the individual woman [1]. Pfizer anticipates that DUAVEE will be available in the U.S. in the first quarter of 2014. This is the first approval of DUAVEE in any country worldwide.

There are approximately 33 million women in the United States between the ages of 45-59, [3] and the average age of menopause in the U.S. is 51 [4]. Based on survey data, an estimated 50% of postmenopausal women experience moderate-to-severe vasomotor symptoms, commonly known as “hot flashes.” [5]

“We know that many women currently experiencing menopausal symptoms are not receiving treatment and have not talked to their doctor about hormone therapy [6]. It is clear that the menopause dialogue needs to improve,” said Gail Cawkwell, MD, PhD, Vice President, Pfizer Medical Affairs. “The approval of DUAVEE, an important, novel and effective treatment, presents a new opportunity for women and their doctors to discuss appropriate options for managing hot flashes and preventing osteoporosis.”

About DUAVEE

Estrogens have been used as hormonal treatments for over 60 years to help manage menopausal symptoms [7]. 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 [7].

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) [2]. DUAVEE uses bazedoxifene - instead of a progestin - to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment [1].

Bazedoxifene was specifically selected to be studied as the SERM in DUAVEE because of its unique pharmacologic profile and mechanism of action, as demonstrated by pre-clinical studies that looked at a number of different SERMs [8]. The pairing of CE with bazedoxifene enables DUAVEE to work selectively in different tissues to activate estrogen receptors in some while inhibiting estrogen activity in others (the uterus) [1]. This pairing allows DUAVEE to offer estrogen efficacy in treating moderate-to-severe hot flashes and preventing postmenopausal osteoporosis while providing an alternative way to help protect the uterine lining from hyperplasia [1].

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 [1].

DUAVEE Clinical Trial Program

The approval is based on Phase III clinical trials in the Selective Estrogens, Menopause, And Response to Therapy (SMART) program. These trials evaluated the safety and efficacy of DUAVEE in generally healthy, postmenopausal women with a uterus for the treatment of moderate-to-severe hot flashes, and the prevention of postmenopausal osteoporosis [1].

Results from one trial demonstrated that DUAVEE significantly reduced the number of moderate-to-severe hot flashes by 74% at 12 weeks, as compared with placebo (47%). This means that prior to starting treatment, women on DUAVEE had on average 10 hot flashes per day while women on placebo had 11. After 12 weeks of treatment, women taking DUAVEE experienced on average three hot flashes per day while women taking placebo had six. In addition, significant decreases in mean hot flash severity were seen at 12 weeks (39%), as compared with placebo (13%) [1].

In other clinical trials, at years one and two, DUAVEE significantly increased bone mineral density in the total hip and lumbar spine from baseline compared with decreases seen with placebo [1].

Some common side effects of DUAVEE include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness and neck pain [1]. Estrogen agonist/antagonists (including bazedoxifene) and estrogens individually are known to increase the risk of venous thromboembolism (VTE), otherwise known as blood clots [1]. Patients should talk regularly with their healthcare providers about how long to stay on treatment with DUAVEE [1].

Given that menstruation does not occur after menopause, clinicians are mindful of any vaginal bleeding that may occur in patients they are treating [4]. In women treated with DUAVEE, the rates of vaginal bleeding and spotting were evaluated and were similar to placebo [1].

FDA Action

The FDA has also issued a Complete Response Letter (CRL) regarding a 0.625mg / 20mg dose of DUAVEE. This was the only dose submitted for a proposed additional indication for vulvar and vaginal atrophy (VVA).

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