In the interests of keeping you informed, I found this article about a new menopause hot flashes medication being tested by Pfizer. It’s an alternative for traditional hormone replacement therapy which has been found to present certain risks.
The article recently appeared in the Wall Street Journal and suggests the new drug called Aprela ”…is a great concept and so far the clinical trials have shown benefit over risk…”
A New Menopause Hot Flashes Medication
Pfizer Inc. is preparing to seek U.S. regulatory approval to sell a new menopause drug that could pose an alternative to the company’s older hormone-replacement therapies, which have been tied to safety risks.
However, repeated delays in developing the new drug, Aprela, have raised questions about its potential. Some analysts and doctors question whether regulators will approve it, and Aprela’s market potential could be limited by continued safety concerns about hormone-based drugs.
The New York-based drug maker expects to submit Aprela for Food and Drug Administration approval sometime this year, according to Olivier Brandicourt, president and general manager of Pfizer’s primary-care unit. He discussed Aprela in an interview earlier this month.
Mr. Brandicourt said the drug has the potential to reduce menopausal symptoms such as hot flashes and to prevent bone-thinning osteoporosis, but with a better safety and tolerability profile than older hormone-replacement therapies.
“We think this is a market which is unsatisfied … and if you can bring a hormone therapy which doesn’t have the traditional side effects, we can actually lead that marketplace,” Mr. Brandicourt told reporters at a November meeting.
Many women stopped using hormone-replacement therapies after a large government study, the Women’s Health Initiative, raised safety concerns a decade ago.
PremPro, which Pfizer acquired with its purchase of Wyeth in 2009, was shown to increase risk of breast cancer. A similar drug, Premarin, has been tied to increased risk of uterine cancer, and both drugs have been linked to risks for stroke and certain blood clots. Pfizer has set aside more than $800 million to cover previous and potential settlements and judgments for lawsuits alleging injuries caused by hormone-replacement therapies.
Aprela contains an active ingredient found in the older drugs, known as conjugated estrogens, which are derived from the urine of pregnant horses. But Aprela combines conjugated estrogens in a single pill with another drug, bazedoxifene, that may mitigate the risks of conjugated estrogens alone.
Bazedoxifene is a selective estrogen receptor modulator, or SERM, the same category as Eli Lilly & Co.’s Evista, which is approved to prevent and treat osteoporosis. A SERM is designed to provide the benefits of estrogen while mitigating the negative effects of estrogen such as increased risk of uterine cancer. Pfizer, via Wyeth, licensed bazedoxifene from Ligand Pharmaceuticals Inc.
[Source] to see what JoAnn Pinkerton, a professor of obstetrics and gynecology at the University of Virginia AND the Food and Drug Administration (FDA) have to say.
Whenever a new menopause hot flashes medication ‘raises its head’, we need to be informed about both its effectiveness AND possible risks. This article does that. Please let us know what you think by leaving a comment below.