Agile Therapeutics, Inc., presented new detailed data on ethinyl estradiol (EE) and levonorgestel (LNG) hormone levels, safety and ovulation suppression on its lead product, AG200-15, an innovative low-dose weekly contraceptive patch now entering Phase 3 clinical trials to show efficacy, safety and tolerability. Agile's proprietary SKINFUSIONTM technology makes it possible to use the trusted hormone combination of ethinyl estradiol and levonorgestrel in a weekly, low-dose patch that is comfortable to wear.
Presented at two poster sessions at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual clinical Meeting, in Chicago, IL, Agile reported that the EE and LNG levels for AG200-15 were consistent over three cycles and within range of low-dose oral contraceptives. In the pharmacokinetic study, EE levels were significantly lower when compared to Levlen, a 30 mcg combination oral contraceptive. AG200-15 will be the first contraceptive patch to offer women a low-dose option consistent with market trends for oral contraceptives.
Data on ovarian suppression indicated that AG200-15's efficacy will be comparable to popular, currently marketed oral contraceptives. The bleeding profile and other hormone related adverse events were similar to published data for low-dose oral contraceptives. Patients reported excellent adhesion and skin tolerability.
According to market research conducted on behalf of Agile with 105 OB/GYN physicians who are significant prescribers of contraception, 89 percent said they would be likely to prescribe AG200-15. If it were available today, almost half said they would prescribe it immediately, showing that physicians recognize a large need with their patients for the comfort and convenience of Agile's low-dose, weekly contraceptive patch. This physician data supports earlier Agile market research with 1,500 women, of whom almost two-thirds who desired contraception said they would ask their doctor about AG200-15 if it were available to them.
Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the University of Southern California, and a member of Agile's Scientific Advisory Board, commented, "In these Phase 2 studies, AG200-15 demonstrated that it delivered a consistent EE level comparable to low-dose oral contraceptives. AG200-15's weekly, low-dose, efficacy and side effect profile will fill a major unmet need for a convenient, safe and efficacious contraceptive."
Marie Foegh, M.D., Chief Medical Officer and Vice President, Clinical Research and Development of Agile, said, "We are happy to share important additional data on our clinical program for Agile's weekly, low-dose contraceptive patch during this very important scientific meeting. Based on the ovulation suppression data, bleeding and hormone related adverse event profile, we selected AG200-15 as the lead contraceptive patch candidate for Phase 3 development."
Pharmacokinetic Study (Monday, Poster #28)
The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, Levlen. As intended, both the EE and LNG exposure of both patches were less than Levlen and consistent with the levels targeted by the company.
Phase 2b Study (Tuesday, Poster #27)
In this multi-centered, multi-cycle Phase 2b safety and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied.
About AG200-15, Agile's Low-Dose Contraceptive Patch
AG200-15 with SKINFUSIONTM technology is a low-dose, weekly contraceptive patch that is entering Phase 3 development with a clearly defined regulatory pathway. SKINFUSIONTM technology makes it possible to utilize the trusted hormone combination of levonorgestrel and ethinyl estradiol in a contraceptive patch. AG200-15 has completed Phase 2 development and met all target endpoints, including providing estrogen dose, ovulation suppression, and side-effect similar to low-dose oral contraceptives. The patch was designed for flexibility and comfort.
About Estrogen
Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of estrogen exposure. In some rare cases, high estrogen levels are thought to be linked with serious, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired.
Source
Agile Therapeutics, Inc.
View drug information on Estradiol Transdermal System.
четверг, 29 сентября 2011 г.
четверг, 22 сентября 2011 г.
Research Lacking On Why Heart Disease Is More Deadly For Women
A woman who has heart disease
is 50% more likely to die from it than a man who has it. Although experts
can point to a number of possible explanations for this, the research on
women and heart disease remains inadequate, says the new edition of a
Harvard Medical School report, The Healthy Heart: Preventing, detecting,
and treating coronary artery disease.
Even though men are more likely to develop cardiovascular disease than
women, about 38% of women who have a heart attack die within a year of the
event, compared with 25% of men. And women are almost twice as likely as
men to have a second heart attack within six years of the first.
The science behind the differences is unclear. These are some of the
theories discussed in The Healthy Heart:
-- Age. Women seem to become more vulnerable to heart disease only
after their estrogen levels fall with menopause, and so they tend
to suffer first heart attacks later than men. Advanced age may
make it more difficult to survive a heart attack.
-- Coronary microvascular disease. This new diagnosis may apply to
50% to 60% of women, compared with 20% of men. These people have
chest pain when they are active or stressed, but on angiograms,
their coronary arteries appear clear. Studies show that women
with coronary microvascular disease have a higher risk for heart
attack or stroke.
-- Inferior diagnosis and treatment. Some studies suggest women's
heart problems don't receive the same attention as men's.
-- Incomplete understanding of symptoms. Classic heart attack
symptoms were defined based on studies on men. These symptoms
don't always occur in women, which may delay diagnosis and
treatment.
Harvard Health Publications
health.harvard.edu
is 50% more likely to die from it than a man who has it. Although experts
can point to a number of possible explanations for this, the research on
women and heart disease remains inadequate, says the new edition of a
Harvard Medical School report, The Healthy Heart: Preventing, detecting,
and treating coronary artery disease.
Even though men are more likely to develop cardiovascular disease than
women, about 38% of women who have a heart attack die within a year of the
event, compared with 25% of men. And women are almost twice as likely as
men to have a second heart attack within six years of the first.
The science behind the differences is unclear. These are some of the
theories discussed in The Healthy Heart:
-- Age. Women seem to become more vulnerable to heart disease only
after their estrogen levels fall with menopause, and so they tend
to suffer first heart attacks later than men. Advanced age may
make it more difficult to survive a heart attack.
-- Coronary microvascular disease. This new diagnosis may apply to
50% to 60% of women, compared with 20% of men. These people have
chest pain when they are active or stressed, but on angiograms,
their coronary arteries appear clear. Studies show that women
with coronary microvascular disease have a higher risk for heart
attack or stroke.
-- Inferior diagnosis and treatment. Some studies suggest women's
heart problems don't receive the same attention as men's.
-- Incomplete understanding of symptoms. Classic heart attack
symptoms were defined based on studies on men. These symptoms
don't always occur in women, which may delay diagnosis and
treatment.
Harvard Health Publications
health.harvard.edu
четверг, 15 сентября 2011 г.
Symbollon Pharmaceuticals, Inc. Evaluates The Clinical Effects Of IoGen(TM) On Fibrocystic Breast Disease
Iodine has been used as an
antimicrobial for the last century. Much has been written about molecular
iodine yet many women suffering from Fibrocystic Breast Disease (FBD) are
unaware that studies being conducted may soon yield an effective
nonhormonal treatment.
While there are several breast cancer drugs on the market, all
available hormonal therapies have significant adverse events. In contrast,
IoGen is a nonhormonal treatment that allows for safe long-term use with
little or no side effects.
"Current research provides substantive support for the initiation of
human clinical studies on the use of molecular iodine as a treatment for
breast disease," stated Paul Desjourdy, President and CEO, Symbollon
Pharmaceuticals, Inc. "The possibility that IoGen may be used as a
treatment for breast cancer makes it all the more important that we
expedite the commercialization time line."
The Company believes IoGen has the ability to eliminate excess cell
growth in female reproductive tissue, including the breast, ovaries and
uterus. Other indications for IoGen include the treatment or prevention of
endometriosis, ovarian cysts, and premenopausal breast cancer.
Symbollon Pharmaceuticals, Inc. is now in FDA Phase III clinical trials
for the evaluation of IoGen (I2) for pain/tenderness associated with FBD
and with potential to treat female reproductive organ cancers.
The importance of (I2) in the treatments for mammary gland dysfunctions
has been corroborated in human and animal models.
Seaweeds, containing high quantities of iodine in several chemical
forms including (I2), have been associated with low incidences of benign
and malignant breast disease in Asian women.
Past studies by independent researchers have supported the possible
effectiveness of molecular iodine (I2) as a treatment for breast cancer.
-- Researchers at Drexel University College of Medicine found that
molecular iodine alters the gene expression profile in the human breast
cancer cells. Dr. Bernard Eskin remarked that these changes may be
responsible for molecular iodine's inhibition of breast cancer
promotion that has been repeatedly observed in animal models.
-- Some researchers investigating the connection between breast tissue and
iodine observed that frequent childbirth and a long lactation period
are known to reduce the risk of breast cancer.
Symbollon is now conducting its IoGen (I2) Phase III pivotal pain
study. Results are expected in first quarter of 2008. For more information
on IoGen(TM), please visit the company's web site at: symbollon or
mybreastpain.
Symbollon Pharmaceuticals, Inc.
symbollon
antimicrobial for the last century. Much has been written about molecular
iodine yet many women suffering from Fibrocystic Breast Disease (FBD) are
unaware that studies being conducted may soon yield an effective
nonhormonal treatment.
While there are several breast cancer drugs on the market, all
available hormonal therapies have significant adverse events. In contrast,
IoGen is a nonhormonal treatment that allows for safe long-term use with
little or no side effects.
"Current research provides substantive support for the initiation of
human clinical studies on the use of molecular iodine as a treatment for
breast disease," stated Paul Desjourdy, President and CEO, Symbollon
Pharmaceuticals, Inc. "The possibility that IoGen may be used as a
treatment for breast cancer makes it all the more important that we
expedite the commercialization time line."
The Company believes IoGen has the ability to eliminate excess cell
growth in female reproductive tissue, including the breast, ovaries and
uterus. Other indications for IoGen include the treatment or prevention of
endometriosis, ovarian cysts, and premenopausal breast cancer.
Symbollon Pharmaceuticals, Inc. is now in FDA Phase III clinical trials
for the evaluation of IoGen (I2) for pain/tenderness associated with FBD
and with potential to treat female reproductive organ cancers.
The importance of (I2) in the treatments for mammary gland dysfunctions
has been corroborated in human and animal models.
Seaweeds, containing high quantities of iodine in several chemical
forms including (I2), have been associated with low incidences of benign
and malignant breast disease in Asian women.
Past studies by independent researchers have supported the possible
effectiveness of molecular iodine (I2) as a treatment for breast cancer.
-- Researchers at Drexel University College of Medicine found that
molecular iodine alters the gene expression profile in the human breast
cancer cells. Dr. Bernard Eskin remarked that these changes may be
responsible for molecular iodine's inhibition of breast cancer
promotion that has been repeatedly observed in animal models.
-- Some researchers investigating the connection between breast tissue and
iodine observed that frequent childbirth and a long lactation period
are known to reduce the risk of breast cancer.
Symbollon is now conducting its IoGen (I2) Phase III pivotal pain
study. Results are expected in first quarter of 2008. For more information
on IoGen(TM), please visit the company's web site at: symbollon or
mybreastpain.
Symbollon Pharmaceuticals, Inc.
symbollon
четверг, 8 сентября 2011 г.
New Treatments for Common Vaginal Infection, Bacterial Vaginosis, Being Studied
Whether a two-week regimen using a stainless steel douching device can eradicate the most common vaginal infection is
under study at the Medical College of Georgia.
MCG researchers want to know whether the device can eliminate bacterial vaginosis and the distinctive odor that typically
accompanies the infection, says Dr. Daron G. Ferris, family medicine physician, director of the Gynecologic Cancer Prevention
Center at MCG Medical Center and the study's principal investigator.
MCG is the only site in the nation for a two-week test of the device that is based on the same premise as stainless steel
bars chefs use to eliminate undesirable odors from their hands. Participants in a small pilot study who used the device for
one week indicated they were beginning to see improvement, says Dr. Eileen D. Dickman, clinical researcher, coordinator of
the Gynecologic Cancer Prevention Center and a co-investigator.
"Bacterial vaginosis is the most common type of vaginal condition that women experience and yet its etiology is poorly
understood," says Dr. Ferris. "Basically it's an alteration of the vagina's ecosystem. It gets that way because the
lactobacilli, the good bacteria in the vagina, are wiped out."
Good bacteria are critical to the vagina's natural, continuous cleansing process. They secrete lactic acid, which makes the
vagina very acidic, and hydrogen peroxide to kill bad bacteria. Dead cells are carried away in the normally clear discharge.
When the system is disrupted, a woman's natural defense against sexually transmitted diseases decreases, leaving her much
more vulnerable to infections such as HIV, Chlamydia and human papillomavirus. Multiplying bad bacteria produce an
undesirable odor and vaginal discharge may be thick and white.
All sexually active women are at risk for this imbalance; for some unknown reason black women have twice the risk. Regular
vaginal douching may also be a factor, says Dr. Ferris, noting that his counterparts around the world might disagree. "In
America we feel that douching is nonselective: it washes out the good and the bad bacteria," says Dr. Ferris. "After you
douche, if the good bacteria isn't re-established first, the bad bacteria take over and you have a potential problem."
Studies and experience have shown that a major reason women douche is because their mothers did, Dr. Ferris says.
While many European physicians encourage the habit, Dr. Ferris is among the many American physicians who advise their
patients against douching. He wonders if the cylindrical stainless steel device, developed collaboratively by researchers at
Abbott Research Group, Inc. and Carnegie Mellon University in Pittsburgh, may one day be a douching technique he'd recommend.
Women can easily use the device in the shower. A compartment attached to the device via a tube is filled with body
temperature tap water and placed at an elevated level so the natural force of gravity gently washes out the vagina for a few
minutes.
"I didn't believe this until they sent me a stainless steel chef's bar to try," says Dr. Ferris. "If you get garlic or onion
on your fingers, you use this stainless steel bar to wash your hands without soap, and it gets rid of the odor. Since
bacterial vaginosis is associated with this odor, it's thought the stainless steel has some effect on the whole process and
it could potentially eliminate the infection and the odor as well. This could be a non-pharmacologic, alternative medicine
approach," says Dr. Ferris.
"The standard treatment today is antibiotics to kill the bad bacteria so hopefully the good bacteria can resume dominance.
The goal of the douching device is to clear the infection without antibiotics. We don't know if it will," says Dr. Ferris.
"But, it might be an option other than antibiotics which are not 100 percent effective and can lead to secondary infections,
including yeast."
MCG also is participating in a multi-site study of the first potential new antibiotic for bacterial vaginosis in at least 25
years, a drug called tinidazole, which already has Food and Drug Administration approval to treat trichomoniasis vaginitis,
another common vaginal infection.
Europeans have used tinidazole for years to treat bacterial vaginosis and experience has shown the drug causes less
gastrointestinal side effects than two antibiotics used routinely in the United States. Its efficacy rate may be equivalent
or better than the existing drugs, clindamycin phosphate and metronidazole, Dr. Ferris says.
"We have had the same two antibiotics for a long time so our treatment options are rather limited," says Dr. Ferris, who is
excited about the opportunity to find better treatments for this very common infection with a recurrence rate of about 80
percent.
Women age 18 and older with bacterial vaginosis are eligible for both studies. The douching study is sponsored by Abbott
Research Laboratories and the antibiotic study by Presutti Laboratories.
Contact: Toni Baker
tbakermcg.edu
706-721-4421
Medical College of Georgia
mcg.edu
View drug information on Clindamycin phosphate topical gel.
under study at the Medical College of Georgia.
MCG researchers want to know whether the device can eliminate bacterial vaginosis and the distinctive odor that typically
accompanies the infection, says Dr. Daron G. Ferris, family medicine physician, director of the Gynecologic Cancer Prevention
Center at MCG Medical Center and the study's principal investigator.
MCG is the only site in the nation for a two-week test of the device that is based on the same premise as stainless steel
bars chefs use to eliminate undesirable odors from their hands. Participants in a small pilot study who used the device for
one week indicated they were beginning to see improvement, says Dr. Eileen D. Dickman, clinical researcher, coordinator of
the Gynecologic Cancer Prevention Center and a co-investigator.
"Bacterial vaginosis is the most common type of vaginal condition that women experience and yet its etiology is poorly
understood," says Dr. Ferris. "Basically it's an alteration of the vagina's ecosystem. It gets that way because the
lactobacilli, the good bacteria in the vagina, are wiped out."
Good bacteria are critical to the vagina's natural, continuous cleansing process. They secrete lactic acid, which makes the
vagina very acidic, and hydrogen peroxide to kill bad bacteria. Dead cells are carried away in the normally clear discharge.
When the system is disrupted, a woman's natural defense against sexually transmitted diseases decreases, leaving her much
more vulnerable to infections such as HIV, Chlamydia and human papillomavirus. Multiplying bad bacteria produce an
undesirable odor and vaginal discharge may be thick and white.
All sexually active women are at risk for this imbalance; for some unknown reason black women have twice the risk. Regular
vaginal douching may also be a factor, says Dr. Ferris, noting that his counterparts around the world might disagree. "In
America we feel that douching is nonselective: it washes out the good and the bad bacteria," says Dr. Ferris. "After you
douche, if the good bacteria isn't re-established first, the bad bacteria take over and you have a potential problem."
Studies and experience have shown that a major reason women douche is because their mothers did, Dr. Ferris says.
While many European physicians encourage the habit, Dr. Ferris is among the many American physicians who advise their
patients against douching. He wonders if the cylindrical stainless steel device, developed collaboratively by researchers at
Abbott Research Group, Inc. and Carnegie Mellon University in Pittsburgh, may one day be a douching technique he'd recommend.
Women can easily use the device in the shower. A compartment attached to the device via a tube is filled with body
temperature tap water and placed at an elevated level so the natural force of gravity gently washes out the vagina for a few
minutes.
"I didn't believe this until they sent me a stainless steel chef's bar to try," says Dr. Ferris. "If you get garlic or onion
on your fingers, you use this stainless steel bar to wash your hands without soap, and it gets rid of the odor. Since
bacterial vaginosis is associated with this odor, it's thought the stainless steel has some effect on the whole process and
it could potentially eliminate the infection and the odor as well. This could be a non-pharmacologic, alternative medicine
approach," says Dr. Ferris.
"The standard treatment today is antibiotics to kill the bad bacteria so hopefully the good bacteria can resume dominance.
The goal of the douching device is to clear the infection without antibiotics. We don't know if it will," says Dr. Ferris.
"But, it might be an option other than antibiotics which are not 100 percent effective and can lead to secondary infections,
including yeast."
MCG also is participating in a multi-site study of the first potential new antibiotic for bacterial vaginosis in at least 25
years, a drug called tinidazole, which already has Food and Drug Administration approval to treat trichomoniasis vaginitis,
another common vaginal infection.
Europeans have used tinidazole for years to treat bacterial vaginosis and experience has shown the drug causes less
gastrointestinal side effects than two antibiotics used routinely in the United States. Its efficacy rate may be equivalent
or better than the existing drugs, clindamycin phosphate and metronidazole, Dr. Ferris says.
"We have had the same two antibiotics for a long time so our treatment options are rather limited," says Dr. Ferris, who is
excited about the opportunity to find better treatments for this very common infection with a recurrence rate of about 80
percent.
Women age 18 and older with bacterial vaginosis are eligible for both studies. The douching study is sponsored by Abbott
Research Laboratories and the antibiotic study by Presutti Laboratories.
Contact: Toni Baker
tbakermcg.edu
706-721-4421
Medical College of Georgia
mcg.edu
View drug information on Clindamycin phosphate topical gel.
четверг, 1 сентября 2011 г.
Weak Bladders Deter Many Young Women From Sports Participation
A weak bladder is putting many young women off participating in sport, or prompting them to give it up altogether, suggests research published ahead of print in the British Journal of Sports Medicine.
The prevalence of urinary stress incontinence, defined as an involuntary leakage of urine, is relatively high among women, with some research putting the figure as high as 46%.
The researchers asked 679 Italian women about whether they had ever had urinary stress incontinence. All them were still having regular periods, and took part in non-competitive sports.
The anomymous responses showed that around 1 in 7 (15%) said they suffered from the condition. On average, the women had been putting up with the symptoms for six years.
Being overweight and having had children boosted the risk of urinary stress incontinence.
Of those affected, almost half said the condition occurred during routine activities, while one in three said it occurred solely during sporting activities. One in five said it occurred in both circumstances.
The most risky sports for women with the problem, in descending order of magnitude, were basketball, athletics, and tennis or squash.
Over half of those complaining of the problem experienced up to three episodes of involuntary leakage a month, but for around one in five the frequency of episodes exceeded more than three a week.
One in 10 women said that stress incontinence had prompted them to give up their favourite sport.
A further one in five said that the condition had restricted or forced them to change their activities, in a bid to avoid the risk of leakage.
The figures would have been considerably higher if women who had gone through the menopause had been included in the sample, say the authors.
They conclude that urinary stress incontinence impacts on the quality of women's lives, affecting many aspects of routine and recreational activities, but few women seek help for the condition, they say.
"They should be given information and offered diagnostic and conservative therapeutic options," including pelvic floor exercises, which can be very helpful, they add.
"The impact of urinary stress incontinence in young and middle aged women practising recreational sports activity: an epidemiological study."
Online First Br J Sports Med 10.1136/bjsm.2008.049072
bjsm.bmj
British Journal of Sports Medicine
The prevalence of urinary stress incontinence, defined as an involuntary leakage of urine, is relatively high among women, with some research putting the figure as high as 46%.
The researchers asked 679 Italian women about whether they had ever had urinary stress incontinence. All them were still having regular periods, and took part in non-competitive sports.
The anomymous responses showed that around 1 in 7 (15%) said they suffered from the condition. On average, the women had been putting up with the symptoms for six years.
Being overweight and having had children boosted the risk of urinary stress incontinence.
Of those affected, almost half said the condition occurred during routine activities, while one in three said it occurred solely during sporting activities. One in five said it occurred in both circumstances.
The most risky sports for women with the problem, in descending order of magnitude, were basketball, athletics, and tennis or squash.
Over half of those complaining of the problem experienced up to three episodes of involuntary leakage a month, but for around one in five the frequency of episodes exceeded more than three a week.
One in 10 women said that stress incontinence had prompted them to give up their favourite sport.
A further one in five said that the condition had restricted or forced them to change their activities, in a bid to avoid the risk of leakage.
The figures would have been considerably higher if women who had gone through the menopause had been included in the sample, say the authors.
They conclude that urinary stress incontinence impacts on the quality of women's lives, affecting many aspects of routine and recreational activities, but few women seek help for the condition, they say.
"They should be given information and offered diagnostic and conservative therapeutic options," including pelvic floor exercises, which can be very helpful, they add.
"The impact of urinary stress incontinence in young and middle aged women practising recreational sports activity: an epidemiological study."
Online First Br J Sports Med 10.1136/bjsm.2008.049072
bjsm.bmj
British Journal of Sports Medicine
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