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News
Viagra for women: Testosterone gel may hold key
Express India News
Feb 14, 2008
Thanks to Viagra, Cialis and Levitra, men with erectile dysfunction can get on
board the Food and Drug Administration-approved love train. But women who
experience a different sexual problem — sagging libido — have been left at the
station. That may be changing.
BioSante Pharmaceuticals Inc. is testing the safety and effectiveness of LibiGel,
a testosterone gel for women designed to combat declines in sexual arousal in
menopause.
The Lincolnshire, Ill.,-based company is conducting two trials, comprising 1,000
women, to test the effectiveness of the gel, which is applied to the upper arm.
If the trials go well, the drug could be available by prescription by 2011.
A testosterone gel for menopausal women makes sense medically, says Dr. Richard
Paulson, professor of reproductive medicine and chief of reproductive
endocrinology at the University of Southern California’s Keck School of
Medicine.
Both men and women produce the female hormone estradiol and the male hormone
testosterone, but in different quantities. Women in menopause lose almost all of
their estradiol production and most of their testosterone production.
Estrogen ( taken orally or topically applied) helps keep the vaginal tissue
strong and elastic, but it doesn’t enhance libido.
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Generic Fosamax Approved
FDA News
February 6, 2008
The U.S. Food and Drug Administration today approved the first generic versions
of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition
that causes thinning and weakening of a person's bones.
Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture
alendronate sodium tablets in three once-daily dosing strengths (5 milligrams,
10 milligrams, and 40 milligrams) and two once-weekly dosing strengths (35
milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, N.J., was
approved to manufacture a 70 milligrams once-weekly dose of the drug.
"The FDA works to assure the safety and efficacy of generic drugs through a
rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph,
director of the FDA's Office of Generic Drugs. "These approvals will provide
generic options for patients who take Fosamax for their osteoporosis."
Fosamax is among the top 100 most frequently dispensed drugs in the United
States, according to the trade magazine Drug Topics.
Generic drug manufacturers must demonstrate that a generic drug has the same
active ingredient, dosage form, strength, route of administration, quality and
performance characteristics, among other things, as the approved brand-name
drug.
The labeling of the generic alendronate sodium tablets may differ from that of
Fosamax because some portions of the labeling are protected by patents and
exclusivity.
For more information visit FDA's Office of Generic Drugs: www.fda.gov/cder/consumerinfo/generic_equivalence.htm
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Pine Tree Extraction may Act as Natural "Viagra" for Erectile
Dysfunction
Medindia News
December 4, 2007
Men suffering from erectile dysfunction (ED), a sexual disorder characterised by
the inability to develop or maintain an erection of the penis, may now look to
the French maritime pine tree for natural Viagra.
A new study at the Medical University of Sofia, Bulgaria, has shown that Prelox-a
blend of Pycnogenol, the extract from the bark of the pine tree, and L-Arginine
aspartate, an amino acid-can improve the condition of men with erectile
dysfunction naturally.
Prelox was found to improve the performance of effected men in just one day
during the study, to be published in an upcoming edition of the International
Journal of Impotence Research.
The study investigated the mechanism involved in relaxation of arteries as it is
required for improved blood flow in erectile function.
It was found that Prelox markedly increased the production of nitric oxide, the
key mediator involved in expanding arteries for elevated blood flow during
erections.
By the end of the study, all men taking Prelox experienced almost a 100 percent
increase of orgasmic function, sexual desire, intercourse satisfaction and
overall satisfaction.
Pycnogenol, an ingredient of Prelox, contains powerful bioflavonoids that
originate from plants and help keep blood vessels dilated for optimal blood flow.
L-Arginine, an amino acid found in many foods, is the other ingredient that
promotes blood flow upon blending with Pycnogenol.
Dr. Steven Lamm from New York University School of Medicine has revealed that
Pycnogenol and L-Arginine work together to enhance nitric oxide, a crucial
chemical for sexual arousal.
He believes that Prelox is the perfect solution for men who want the same
outcome as other prescription nitric oxide enhancers, but with a natural
approach.
During the study, 50 patients with moderate erectile problems were asked to take
two Prelox or placebo tablets in the morning and evening.
The erectile quality of men was observed through questionnaires. The researchers
also collected the subjects’ semen, spermatozoa, and blood samples to measure
nitric oxide and testosterone.
The study consisted of a four-week period, followed by a wash-out period,
another four-week period, and a final washout.
At the end of the treatment period, patients treated with Prelox achieved high
questionnaire scores, whereas the placebo group had no significant effects.
After one month on Prelox, the patients’ erectile quality appeared almost as
healthy as that of twenty-year-old men. The mean number of intercourse also
almost doubled during treatment for those who took Prelox.
The placebo group, on the other hand, did not show any changes in the production
of nitric oxide activity...
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Viagra Increases Release of Reproductive Hormone: Study
Medindia News
August 24, 2007
The little blue pill may do more than get the blood pumping. Sildenafil - the
generic name for Viagra - also increases release of a reproductive hormone in
rats, according to a new study.
Researchers at the University of Wisconsin-Madison report this month that
sildenafil increases the amount of oxytocin released by stimulation of the
posterior pituitary gland, a small structure directly underneath the brain that
regulates hormone levels in response to neural signals.
The finding is the first indication of a chemical mechanism through which
erectile dysfunction drugs like Viagra may have physical effects besides
increasing blood flow to sexual organs, says study author Meyer Jackson, a
physiology professor at the UW-Madison School of Medicine and Public Health.
Sometimes called the "love hormone" or "cuddle chemical," oxytocin plays several
important roles in social interactions and reproduction, including triggering
uterine contractions and lactation. It is also released during orgasm and has
been linked to sexual arousal.
Oxytocin release is regulated by an enzyme that acts like a braking system,
limiting hormone release by dampening neural excitation of the cells. This same
enzyme, phosphodiesterase type 5, also limits blood flow by contracting the
muscles around blood vessels.
In both places, sildenafil works by blocking this enzyme, essentially releasing
the brakes, explains Jackson. In blood vessels, relaxing smooth muscle increases
blood flow, which corrects erectile dysfunction, and in the posterior pituitary,
the cells become more responsive. "The same stimulation will produce more [oxytocin]
release."...
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