Wyeth on Thursday said that regulatory approval of its new drug, Pristiq, a nonhormonal treatment for hot flashes and other menopause symptoms, is delayed until at least July to give FDA time to review new data on the drug, the AP/Forbes reports. FDA was scheduled to decide whether to approve Pristiq next week. The drug is a new version of Wyeth’s depression treatment Effexor, which will lose patent protection in 2010. According to the AP/Forbes, Wyeth is seeking approval from FDA to market Pristiq as a depression treatment for older women, as well as a treatment for menopause symptoms. FDA’s review of the drug as a depression treatment also will be delayed (Perrone, AP/Forbes, 4/19). Company officials in a conference call with analysts on Thursday said that they are sending FDA data showing effectiveness but improved tolerability for a lower dose, 50-milligram dose of Pristiq, Reuters reports. The company expects that Pristiq will be approved to treat hot flashes in the third quarter of 2007 but that approval to treat depression will not come until the first quarter of 2008 (Reuters, 4/19).
November 30, 2009
Identification Of Genetic Variants Affecting Age At Menopause Could Help Improve Fertility Treatment
For the first time, scientists have been able to identify genetic factors that influence the age at which natural menopause occurs in women. Ms Lisette Stolk, a researcher from Erasmus MC, Rotterdam, The Netherlands, told the annual conference of the European Society of Human Genetics that a greater understanding of the factors influencing age at menopause might eventually help to improve the clinical treatment of infertile women.
Ms Stolk and her team performed a Genome-Wide Association Study (GWAS) in 10,339 menopausal women. The data analysed were taken from 9 different studies undertaken in The Netherlands (the Rotterdam Study 1 and 2), the UK (the TwinsUK study), USA (the Framingham study, the Cardiovascular Health Study, the ARIC study, the HAPI Heart Study), Iceland (AGES-Reykjavik) and Italy (the InCHIANTI study). The scientists found 20 single nucleotide polymorphisms (SNPs) in four different places on chromosomes 19 and 20. SNPs are common genetic variants that influence how humans look, behave, develop disease or react to pathogens. In genetics they are used to compare regions of the genome between different groups of individuals and to identify those regions that are associated with a particular disease or characteristic. The SNPs the researchers found had not been identified before, and the part of the body where they might have an effect has yet to be identified, though the researchers speculate that this is likely to be in the ovaries or brain.
“We found that the 20 SNPs were all related to a slightly earlier menopause”, said Ms Stolk, “and women who had one of them experienced menopause nearly a year earlier than others. We know that ten years before menopause women are much less fertile, and five years before many are infertile. In Western countries, where women tend to have children later in life and closer to menopause, age at menopause can be an important factor in whether or not a particular woman is able to become a mother.”
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More Women Seek Nonprescription Remedies For Menopause Symptoms
Over-the-counter remedies for menopause symptoms are growing in popularity among some women who fear potential risks from prescription hormone replacement therapy, the New York Times reports. According to the Times, the market for alternative therapies — such as natural supplements and topical creams — jumped in 2002 after initial results from the Women’s Health Initiative suggested that HRT could increase risk for heart disease, cancer, stroke and blood clots.
Gynecologists estimate that about one-third of menopausal women are treated with conventional prescription hormones, and about one-third are treated with bio-identical hormones — plant-derived synthetic hormones that mimic the molecular structure of human hormones. The remaining one-third either do not seek therapy for symptoms, are not bothered by symptoms or use over-the-counter therapies. There are more than 500 over-the-counter products available that claim to alleviate menopause symptoms, the Times reports. The treatments include such products as teas, low-dose progesterone creams, black cohosh capsules and phytoestrogens derived from soy and red clover, according to the Times. According to Nutrition Business Journal, the U.S. dietary supplement market associated with menopause increased from $211 million in 1999 to $337 million in 2007.
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Nutri5(R) And Brain Health Related To Treatment Of Menopausal Symptoms
Earlier this year, the BBC reported that “HRT – Hormone Replacement Therapy – can shrink women’s brains”1, after a study was published which showed that brain volume in women taking HRT was smaller in two key areas involved in thinking and memory.
This comes in addition to earlier results from the Women’s Health Initiative (WHI) Memory Study2 that linked HRT to an increased risk of memory loss and dementia, and an article in the Lancet3 which concluded that HRT “substantially increases the risk of dementia of any cause and cognitive* decline” (* memory, thinking and understanding).
This adds to the growing body of evidence that the risks of HRT far outweigh any perceived benefits, evidence that Nutri Pharma feels needs to be brought to the attention of the 150,000 women in Norway and millions of women across Europe who are still being prescribed this treatment.
Nutri5® is Nutri Pharma’s natural product for the relief of menopausal symptoms, shown to be effective in an open pilot study. In addition to reducing menopausal symptoms, improving heart health and reducing the risk of osteoporosis, clinical trials4 on soy diets containing high levels of soy isoflavones like those found in Nutri5® have also shown that, unlike HRT, these can actually improve the cognitive function of post-menopausal women (aged 45+). (more…)