FDA Approves Bazedoxifene and Conjugated Estrogens to Treat Hot Flashes and Prevent Osteoporosis


Bazedoxifene 198481-32-2 FDA ApprovalOn October 3, 2013 the FDA approved the new medication Duavee, comprised of Bazedoxifene and conjugated estrogens (Premarin) to treat hot flashes in postmenopausal women. The unique ability of this novel treatment to curtail hot flashes and help prevent osteoporosis is encouraging for gynecologists and their female patients who are experiencing post-menopause. The combination of conjugated estrogens and the estrogen agonist Bazedoxifene is considered to be a safe alternative to debilitating hot flashes, which is a result of increased vasomotor activity.  This treatment is intended for women who are post-menopausal and still have a uterus, and should be used for a short period of time only. The dynamic combination of conjugated estrogens and Bazedoxifene is not intended as a first line treatment for osteoporosis, but it is an effectual and tolerable option for women who need both the hormonal assistance, and who are at a significant risk for this bone destroying disease. Studies have offered reassurance for women who may have concerns regarding risks of endometrial hyperplasia or uterine cancer after using this drug combination. The addition of Bazedoxifene to the conjugated estrogens curtails excessive growth of the uterine lining, making risks low for women concerned with their uterine cancer risk. Studies of Duavee have not revealed severe adverse events, and most women experience minimal side effects, which have included mild nausea, dizziness and stomach upset.

Approved as an easy to remember once daily pill, this combination treatment of Bazedoxifene and conjugated estrogens is available as a 20 mg/0.45 mg tablet. Patients who have had certain female cancers, blood clots or a history of stroke and heart attack are not candidates for this post-menopausal treatment.  Positive data emerged from Phase III clinical trials, which were coined SMART, or the Selective Estrogens, Menopause, And Response to Therapy program.  The FDA based their timely approval of this formidable combination treatment based on the excellent results from the Phase III SMART trial.

Of the women who participated in the SMART trial a significant 74 percent experienced a sizable reduction in their hot flashes after 12 weeks of treatment, as compared to 47 percent of women who received a placebo. Other trials of Duavee have revealed encouraging data regarding the bone density of women who were dosed with this post-menopausal treatment. Female participants in these aforementioned trials demonstrated greatly increased bone mineral density scores after between one and two years treatment with this conjugated estrogens and Bazedoxifene drug.  Patients can expect to see this novel treatment in pharmacies in the early half of 2014.

The FDA approval of conjugated estrogens and Bazedoxifene CAS# 198481-32-2,  is an exciting opportunity for research and development. LGM Pharma provides the Bazedoxifene API for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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