Women using depot medroxyprogesterone acetate (DMPA), commonly known as the birth control shot, gained an average of 11 pounds and increased their body fat by 3.4 percent over three years, according to researchers at the University of Texas Medical Branch (UTMB).
However, women who switched to nonhormonal contraception began to slowly lose the weight and fat mass they gained - nearly four pounds over two years, while those who used oral contraception after the shots gained an average of four additional pounds in the same time span. The amount of weight gain was dependent on the length of time DMPA was used, as the rate of weight gain slowed over time.
The study, which appears in the March 4 issue of the American Journal of Obstetrics and Gynecology, is one of the most comprehensive studies of its kind.
DMPA is an injected contraceptive administered to patients every three months. More than two million American women use DMPA, including approximately 400,000 teens. DMPA is relatively inexpensive compared to some other forms of birth control, has a low failure rate and doesn't need to be administered daily, which contributes to the contraceptive's popularity.
"Women and their doctors should factor in this new data when choosing the most appropriate birth control method," said lead author Abbey Berenson, M.D., professor in the Department of Obstetrics and Gynecology and director of the Center for Interdisciplinary Research in Women's Health at UTMB.
"One concern is DMPA's link to increased abdominal fat, a known component of metabolic syndrome, which increases the risk of cardiovascular disease, stroke and diabetes," said Berenson.
The study followed 703 women in two age categories, 16- to 24-years-old, and 25- to 33-years-old, using DMPA, oral (desogestrel) or nonhormonal (bilateral tubal ligation, condom or abstinence) contraception for three years. DMPA users who discontinued this method and selected another form of birth control were followed for up to two additional years. Throughout the course of the study, researchers compared changes in body weight and composition and took into account the influence of age, race, caloric intake and exercise, among other factors.
When researchers compared all three groups, DMPA users were more than twice as likely as women using nonhormonal or oral birth control to become obese over the next three years. "The findings are worrisome; however, more research is needed to determine if DMPA use directly contributes to obesity-related conditions and puts patients' overall health at risk," said Berenson.
Women using oral contraception did not gain more weight than those using a nonhormonal form of birth control. However, the study found that their body fat increased slightly while their lean body mass (muscle) decreased. Researchers said this was less likely among those women who exercised regularly and consumed a healthy diet that included increased protein intake.
The study will enable physicians to counsel women accurately about the body changes associated with widely used forms of contraception and also shed light on how weight gain might be reversed, said Berenson.
According to Berenson, the mechanism by which DMPA causes an increase in weight gain and fat mass is not known, and no connection was found between DMPA use and caloric intake, fat consumption or amount of exercise on body mass changes. The findings seem to argue against the theory that weight gain could be due to the drug's perceived effects on increased caloric intake and decreased energy expenditure, but ongoing research is needed to confirm or discount varying possible explanations, she said.
UTMB researchers are conducting follow-up studies to determine which subset of women is most likely to gain weight on DMPA. Berenson noted that in ongoing research, preliminary data has shown that approximately 25 percent of women on DMPA experience significant and potentially dangerous body composition changes.
Notes:
The study was supported by the National Institute of Child Health & Human Development. Mahburbur Rahman, MBBS, PhD, MPH, Research Scientist, Center for Interdisciplinary Research in Women's Health, contributed to this research.
About the University of Texas Medical Branch
The University of Texas Medical Branch at Galveston (UTMB) is a major academic health center dedicated to improving the lives of others through health sciences education, clinical care and biomedical research. Opened in 1891, UTMB combines a rich history of service with a forward-thinking spirit to define the future of health care nationally and internationally. www.utmb.edu
Source: Olivia Goodman
University of Texas Medical Branch at Galveston
четверг, 26 апреля 2012 г.
четверг, 19 апреля 2012 г.
Urinary Incontinence Effectively Treated Long Term Using Muscle Stem Cells
Women with stress urinary incontinence (SUI) treated using muscle-derived stem cell injections to strengthen their sphincter muscles experience long-term improvements in their condition, according to a study led by researchers at the University of Pittsburgh School of Medicine and Sunnybrook Health Sciences Centre in Toronto. The study, which followed patients for more than one year, suggests that the approach is safe, improves patients' quality of life and may be an effective treatment for SUI. The findings were presented at the Tissue Engineering and Regenerative Medicine in Urology press briefing at the annual meeting of the American Urological Association (AUA) in San Diego, and is published in Abstract 1331 in the AUA proceedings.
"This clinical trial is extremely encouraging, given that 13 million people in the United States, most of them women, cope with stress urinary incontinence," said Michael B. Chancellor, M.D., the study's senior author and professor of urology and gynecology at the University of Pittsburgh School of Medicine. "We're demonstrating for the first time that we may be able to offer people with SUI a long-term and minimally invasive treatment option."
"The technique to achieve optimal efficacy is evolving, but we are pleased with what this study has shown," added principal investigator Lesley Carr, M.D., urologist at Sunnybrook Health Sciences Centre and assistant professor at the University of Toronto. "We now have preliminary evidence that stem cells are safe to use and appear to improve female stress urinary incontinence."
Previous studies in animal models of SUI completed at the University of Pittsburgh School of Medicine demonstrated that injecting stem cells into the urethral muscles increases leak point pressure, leading to the restoration of the deficient muscles. The results of these studies formed the basis for the clinical trial.
In the study, Dr. Carr and colleagues took biopsies of skeletal muscle tissue from eight female patients and isolated and expanded the stem cells from the tissue in culture. In an outpatient setting, the patients then received injections of the muscle-derived stem cells into the area surrounding the urethra. Each patient received an equal dose of stem cell injections using three different injection techniques - a transurethral injection with either an 8-mm or 10-mm needle or a periurethral injection.
Five of the eight women who participated in the study reported improvement in bladder control and quality of life with no serious short- or long-term adverse effects one year after the initial treatment. These improvements were associated with both the 10-mm needle injections and the periurethral injections, which allowed the investigators to deliver the stem cells close to the damaged sphincter muscle. The 8-mm needle was not able to deliver the muscle stem cells deep enough into the tissue to reach the sphincter.
A multi-center study in Canada and a study in the United States are currently underway and will allow researchers to determine the optimal dose of muscle stem cells needed to effectively treat SUI.
Women with SUI involuntarily leak urine during activities that put pressure on the bladder, such as running, coughing, sneezing or laughing. Stress incontinence is caused by childbirth, menopause or pelvic surgery and is most often diagnosed in women during middle-age.
CONTACT: Natalie Chung-Sayers,
Sunnybrook Health Sciences Centre
In addition to Drs. Carr and Chancellor, other contributors to the study included Deborah Steele and Shannon Steele, with Sunnybrook Health Sciences Centre; Janet Erickson and Wendy Leng, M.D., with the University of Pittsburgh; and David Wagner, Ryan Pruchnic and Ron Jankowski with Cook MyoSite Inc. The study was funded by Cook MyoSite Inc. of Pittsburgh. Dr. Chancellor serves as a paid consultant to CookMyoSite and maintains a financial interest in the company.
Contact: Clare Collins
University of Pittsburgh Schools of the Health Sciences
"This clinical trial is extremely encouraging, given that 13 million people in the United States, most of them women, cope with stress urinary incontinence," said Michael B. Chancellor, M.D., the study's senior author and professor of urology and gynecology at the University of Pittsburgh School of Medicine. "We're demonstrating for the first time that we may be able to offer people with SUI a long-term and minimally invasive treatment option."
"The technique to achieve optimal efficacy is evolving, but we are pleased with what this study has shown," added principal investigator Lesley Carr, M.D., urologist at Sunnybrook Health Sciences Centre and assistant professor at the University of Toronto. "We now have preliminary evidence that stem cells are safe to use and appear to improve female stress urinary incontinence."
Previous studies in animal models of SUI completed at the University of Pittsburgh School of Medicine demonstrated that injecting stem cells into the urethral muscles increases leak point pressure, leading to the restoration of the deficient muscles. The results of these studies formed the basis for the clinical trial.
In the study, Dr. Carr and colleagues took biopsies of skeletal muscle tissue from eight female patients and isolated and expanded the stem cells from the tissue in culture. In an outpatient setting, the patients then received injections of the muscle-derived stem cells into the area surrounding the urethra. Each patient received an equal dose of stem cell injections using three different injection techniques - a transurethral injection with either an 8-mm or 10-mm needle or a periurethral injection.
Five of the eight women who participated in the study reported improvement in bladder control and quality of life with no serious short- or long-term adverse effects one year after the initial treatment. These improvements were associated with both the 10-mm needle injections and the periurethral injections, which allowed the investigators to deliver the stem cells close to the damaged sphincter muscle. The 8-mm needle was not able to deliver the muscle stem cells deep enough into the tissue to reach the sphincter.
A multi-center study in Canada and a study in the United States are currently underway and will allow researchers to determine the optimal dose of muscle stem cells needed to effectively treat SUI.
Women with SUI involuntarily leak urine during activities that put pressure on the bladder, such as running, coughing, sneezing or laughing. Stress incontinence is caused by childbirth, menopause or pelvic surgery and is most often diagnosed in women during middle-age.
CONTACT: Natalie Chung-Sayers,
Sunnybrook Health Sciences Centre
In addition to Drs. Carr and Chancellor, other contributors to the study included Deborah Steele and Shannon Steele, with Sunnybrook Health Sciences Centre; Janet Erickson and Wendy Leng, M.D., with the University of Pittsburgh; and David Wagner, Ryan Pruchnic and Ron Jankowski with Cook MyoSite Inc. The study was funded by Cook MyoSite Inc. of Pittsburgh. Dr. Chancellor serves as a paid consultant to CookMyoSite and maintains a financial interest in the company.
Contact: Clare Collins
University of Pittsburgh Schools of the Health Sciences
четверг, 12 апреля 2012 г.
Blogs Comment On HHS Conscience Rule, Frozen Embryos, 'Mexico City' Policy
The following summarizes selected women's health-related blog entries.
~ "Repeal the Global Gag Rule," Rep. Nita Lowey (D-N.Y.), Huffington Post blogs: President-elect Barack Obama and the new Congress "can place American foreign policy firmly on the side of free speech, of women's health, and of doctors and care providers who understand that family planning is a cornerstone of social stability, economic growth and public health in the developing world" by repealing the "global gag rule," also called the Mexico City policy, Lowey writes in a blog entry. This step can be done "quickly, simply, cleanly, without a penny of cost to the taxpayers," she adds. The rule would be "patently unconstitutional" if applied in the U.S., Lowey writes. She continues, "Abroad, [the rule] is responsible for untold misery and, in tragic irony, has almost certainly increased the number of unintended pregnancies and put millions of women's and children's lives at risk." Lowey writes that as a Representative, her "fight to overturn [the rule] has been stymied by Republican majorities" and threatened by a veto from President Bush. She writes that she looks forward to working with the Obama administration to finally repeal the rule, concluding, "Few actions would benefit more people with less effort, or send a more dramatic signal to the world that America is prepared once again to be a leader for individual rights, personal dignity and commonsense policy that saves lives" (Lowey, Huffington Post blogs, 12/11).
~ "Conscience Clauses: Justifying Bigotry on Religious Grounds," Pamela Merritt, RH Reality Check: Merritt writes, "The thought of people refusing to serve a person of color due to their personal objection to desegregation is now considered indefensible and a violation of the law, but refusal of service due to personal religious objections is not a thing of the past." Refusals to provide health care services or fill prescriptions are "threats to the rights and health of women, and defending against those threats and the erosion of rights that they represent is a crucial front in the reproductive justice struggle," according to Merritt. She writes that a "key question" regarding health care conscience rules -- which allow providers to refuse services based on moral or religious beliefs -- is "whether a health care insurance provider can refuse to cover services on religious grounds if they receive federal funds." One example is the Catholic health care system, which the group Catholics for Choice has examined in a report, Merritt writes. According to Merritt, the report found that there are "few formal regulations that require health plans that refuse to provide family planning services to disclose this clearly on marketing and enrollment materials," which can lead employers to "select a plan and have no idea that it limits or denies access to reproductive health care due to a lack of coverage." She continues, "It's not as if there aren't ways to balance individual freedoms," noting that the report identified several methods for Catholic health care plans to offer access to reproductive health services "without compromising their ... beliefs." She writes that the "key element" for Catholic systems is "distancing the Catholic plan from the direct provision of and/or direct payment for forbidden services," such as by contracting with a non-Catholic provider or arranging payment for reproductive health services through a third party (Merritt, RH Reality Check, 12/11).
~ "'Embryos on Ice' ... and Other Absurdities," Judie Brown, American Life League blog: The "most heartless" term used to describe "preborn children" is "'Embryos on Ice,'" Brown writes in response to recent news coverage regarding options for excess frozen embryos created for fertility treatments. Brown writes that "we are talking about children," not "'fertilized eggs' or 'leftovers' or rejects tossed off an assembly line." She continues that the parents of these embryos "have unwittingly contributed to the ongoing growth of the culture of death by agreeing with the hypothesis that there are embryonic children who are somehow less human than those who were implanted in their mom and brought to term ... as if there are some embryonic children who are really children and others who are not." Fertility treatments are creating a "dehumanization" that is "unhealthy for parents, the children that have been welcomed and the children who may be killed ... or simply left in a tray somewhere to die," she writes. She concludes, "By restoring the legal recognition of personhood to every innocent human being from his beginning, practices such as [in vitro fertilization] will cease, because every human embryo will have the very same rights you and I have" (Brown, American Life League blog, 12/10).
~ "Pro-Lifers Love Babies So Much They Want To Defund Planned Parenthood So That You Get Pregnant," Feministe: "For most of us, the fact that [Planned Parenthood] provides contraception to low-income women and teenagers is a good thing, because it means fewer unwanted pregnancies (and fewer abortions)," a Feministe blog entry says. Although abortion services comprise only 3% of Planned Parenthood's budget, "for anti-choice leaders, contraception and abortion are part of the same problem: They allow women to 'get away' with having sex, and that is a big problem in their ideal world." The blog continues that people are losing their health insurance coverage because of the current economic crisis and high unemployment rate, adding that it is "abhorrent that anti-choicers would choose this moment to try and strip resources to one of the country's largest providers of reproductive health care -- especially a provider that offers crucial services like contraception and cancer screenings." The blog concludes, "Shame on anti-choicers for their politically motivated targeting of [Planned Parenthood] -- and their attempts to block low-income women from accessing basic reproductive care" (Feministe, 12/11).
~ "W's Parting Gifts to Women," Martha Burk, Huffington Post blogs: President Bush is giving women "some new regulations that will keep on giving us trouble for years to come" before he leaves office, Burk writes in a blog entry. Burk adds that Bush is "deputizing health workers as watchdogs" through the proposed HHS conscience rule, which would permit health providers who receive federal grants to opt out of medical care based on their moral or religious beliefs, because he "know[s] that the country is not inclined to support new laws against abortion." Another "gift" Bush is giving women is "a weakening of our already very weak" Family and Medical Leave Act by "making it harder for workers to exercise their rights" under the law, Burk writes. Bush also is giving "new premiums and higher co-payments for Medicaid" to low-income women, Burk says, adding that experts have predicted the changes will "cause Medicaid patients to go without medical services." Burk adds, "[W]ith the economy in shambles and two wars to worry about, these concerns will most likely be pushed to the bottom of the pile for at least a couple of years," concluding, "After that, the process [to overturn the regulations] could take up to a year and a half" (Burk, Huffington Post blogs, 12/11).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2008 The Advisory Board Company. All rights reserved.
~ "Repeal the Global Gag Rule," Rep. Nita Lowey (D-N.Y.), Huffington Post blogs: President-elect Barack Obama and the new Congress "can place American foreign policy firmly on the side of free speech, of women's health, and of doctors and care providers who understand that family planning is a cornerstone of social stability, economic growth and public health in the developing world" by repealing the "global gag rule," also called the Mexico City policy, Lowey writes in a blog entry. This step can be done "quickly, simply, cleanly, without a penny of cost to the taxpayers," she adds. The rule would be "patently unconstitutional" if applied in the U.S., Lowey writes. She continues, "Abroad, [the rule] is responsible for untold misery and, in tragic irony, has almost certainly increased the number of unintended pregnancies and put millions of women's and children's lives at risk." Lowey writes that as a Representative, her "fight to overturn [the rule] has been stymied by Republican majorities" and threatened by a veto from President Bush. She writes that she looks forward to working with the Obama administration to finally repeal the rule, concluding, "Few actions would benefit more people with less effort, or send a more dramatic signal to the world that America is prepared once again to be a leader for individual rights, personal dignity and commonsense policy that saves lives" (Lowey, Huffington Post blogs, 12/11).
~ "Conscience Clauses: Justifying Bigotry on Religious Grounds," Pamela Merritt, RH Reality Check: Merritt writes, "The thought of people refusing to serve a person of color due to their personal objection to desegregation is now considered indefensible and a violation of the law, but refusal of service due to personal religious objections is not a thing of the past." Refusals to provide health care services or fill prescriptions are "threats to the rights and health of women, and defending against those threats and the erosion of rights that they represent is a crucial front in the reproductive justice struggle," according to Merritt. She writes that a "key question" regarding health care conscience rules -- which allow providers to refuse services based on moral or religious beliefs -- is "whether a health care insurance provider can refuse to cover services on religious grounds if they receive federal funds." One example is the Catholic health care system, which the group Catholics for Choice has examined in a report, Merritt writes. According to Merritt, the report found that there are "few formal regulations that require health plans that refuse to provide family planning services to disclose this clearly on marketing and enrollment materials," which can lead employers to "select a plan and have no idea that it limits or denies access to reproductive health care due to a lack of coverage." She continues, "It's not as if there aren't ways to balance individual freedoms," noting that the report identified several methods for Catholic health care plans to offer access to reproductive health services "without compromising their ... beliefs." She writes that the "key element" for Catholic systems is "distancing the Catholic plan from the direct provision of and/or direct payment for forbidden services," such as by contracting with a non-Catholic provider or arranging payment for reproductive health services through a third party (Merritt, RH Reality Check, 12/11).
~ "'Embryos on Ice' ... and Other Absurdities," Judie Brown, American Life League blog: The "most heartless" term used to describe "preborn children" is "'Embryos on Ice,'" Brown writes in response to recent news coverage regarding options for excess frozen embryos created for fertility treatments. Brown writes that "we are talking about children," not "'fertilized eggs' or 'leftovers' or rejects tossed off an assembly line." She continues that the parents of these embryos "have unwittingly contributed to the ongoing growth of the culture of death by agreeing with the hypothesis that there are embryonic children who are somehow less human than those who were implanted in their mom and brought to term ... as if there are some embryonic children who are really children and others who are not." Fertility treatments are creating a "dehumanization" that is "unhealthy for parents, the children that have been welcomed and the children who may be killed ... or simply left in a tray somewhere to die," she writes. She concludes, "By restoring the legal recognition of personhood to every innocent human being from his beginning, practices such as [in vitro fertilization] will cease, because every human embryo will have the very same rights you and I have" (Brown, American Life League blog, 12/10).
~ "Pro-Lifers Love Babies So Much They Want To Defund Planned Parenthood So That You Get Pregnant," Feministe: "For most of us, the fact that [Planned Parenthood] provides contraception to low-income women and teenagers is a good thing, because it means fewer unwanted pregnancies (and fewer abortions)," a Feministe blog entry says. Although abortion services comprise only 3% of Planned Parenthood's budget, "for anti-choice leaders, contraception and abortion are part of the same problem: They allow women to 'get away' with having sex, and that is a big problem in their ideal world." The blog continues that people are losing their health insurance coverage because of the current economic crisis and high unemployment rate, adding that it is "abhorrent that anti-choicers would choose this moment to try and strip resources to one of the country's largest providers of reproductive health care -- especially a provider that offers crucial services like contraception and cancer screenings." The blog concludes, "Shame on anti-choicers for their politically motivated targeting of [Planned Parenthood] -- and their attempts to block low-income women from accessing basic reproductive care" (Feministe, 12/11).
~ "W's Parting Gifts to Women," Martha Burk, Huffington Post blogs: President Bush is giving women "some new regulations that will keep on giving us trouble for years to come" before he leaves office, Burk writes in a blog entry. Burk adds that Bush is "deputizing health workers as watchdogs" through the proposed HHS conscience rule, which would permit health providers who receive federal grants to opt out of medical care based on their moral or religious beliefs, because he "know[s] that the country is not inclined to support new laws against abortion." Another "gift" Bush is giving women is "a weakening of our already very weak" Family and Medical Leave Act by "making it harder for workers to exercise their rights" under the law, Burk writes. Bush also is giving "new premiums and higher co-payments for Medicaid" to low-income women, Burk says, adding that experts have predicted the changes will "cause Medicaid patients to go without medical services." Burk adds, "[W]ith the economy in shambles and two wars to worry about, these concerns will most likely be pushed to the bottom of the pile for at least a couple of years," concluding, "After that, the process [to overturn the regulations] could take up to a year and a half" (Burk, Huffington Post blogs, 12/11).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2008 The Advisory Board Company. All rights reserved.
четверг, 5 апреля 2012 г.
Rights To Commercialise World's First Contraceptive Spray Acquired By Acrux
Acrux (ASX:ACR), the Australian company with patient-preferred technology for delivering drugs across the skin, today announced an agreement with the New York-based Population Council, Inc. The agreement enables Acrux to progress toward commercialisation of a unique contraceptive spray, containing the new-generation contraceptive drug Nestorone?®.
Under the agreement, Acrux has a worldwide licence from the Population Council to intellectual property covering the use of Nestorone?® with Acrux's patented metered-dose skin spray delivery technology (MDTS?®). Acrux will develop and commercialise Nestorone?® MDTS?® and has the right to sub-license to commercial partners. In addition to commercial distribution of the product, Acrux (or its sub-licensees) will make Nestorone?® MDTS?® available at reduced prices to public sector organisations providing human reproductive health products to disadvantaged people.
Results of a Phase 1 clinical trial, conducted by Acrux last year under a development agreement with the Population Council, showed that a once daily application of Nestorone?® MDTS?® provides the level of Nestorone?® in the blood known to be effective for contraception. A Phase 2 trial, scheduled to start in the second half of 2006, aims to demonstrate that Nestorone?® MDTS?® controls ovulation. Acrux will seek commercial partners for the remaining steps in global commercialisation.
"This exciting product will give women a very attractive new option for contraception. It combines our unique technology with the know-how of one of the world's leading developers of reproductive health products," said Acrux CEO Igor Gonda.
"The target features of Nestorone?® MDTS?® are: a convenient daily spray onto the arm that is more discreet and less irritating to the skin than a patch, and we believe, will prove to have a better safety profile than other hormonal contraceptives. Market research has shown that many women will prefer the ease and convenience of this method to swallowing pills, taking injections, or wearing patches," he added.
Gonda also noted that Acrux sees great market potential for Nestorone?® MDTS?® given the fact that annual worldwide sales of hormonal contraceptives exceed US$4 billion, and sales of transdermal contraceptive patches in the United States alone are more than US$400 million a year.
Population Council CEO Peter Donaldson said he was pleased with the progress Acrux had made in the validation of its transdermal spray technology platform in clinical trials, especially in the area of women's health. "We are very encouraged by the results obtained so far with the Nestorone?® spray. An important part of the Population Council's mission is to meet the need for reproductive healthcare products on a global scale, and we believe that Acrux's technology can be an attractive option for many women around the world."
Acrux has two other products in its women's health portfolio that are delivered as daily sprays; Evamist for menopausal symptoms and Testosterone MDTS?® for decreased libido. Both are in advanced stages of development.
About Nestorone?® MDTS?®
Nestorone?®, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS?® is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug via the skin. The spray applicator is placed gently against the forearm and an actuator button is pushed. A light spray containing a proprietary formulation of Nestorone?® is quickly absorbed into the skin. Nestorone?® is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen. The spray is fast-drying, non-irritating, and invisible after application.
About Acrux
acrux.au/
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
Acrux's product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders and a contraceptive. 20 human clinical trials have been completed with 8 different drugs and the lead product, Evamist, is nearing the end of a phase 3 trial in the USA.
Acrux has licensed USA rights for Evamist (Estradiol MDTS?®) and Testosterone MDTS?® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS?® and Fentanyl UDTS to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.
About the Population Council popcouncil/
The Population Council, an international, non-profit, non-governmental organisation, seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Population Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
The Population Council has a proven track record in the successful development of female contraceptive products and has worked to make them accessible to people in developing countries. Three of the four major longacting reversible contraceptives available today were developed by the Population Council: the Copper T IUD, Norplant?®, Jadelle?®, and Mirena?®.
More than 50 million Copper T IUDs have been distributed in over 70 countries.
CONTACTS:
Acrux
USA: - Igor Gonda, CEO & Managing Director +61 439 811 339
Australia: - Jon Pilcher, CFO +61 3 8379 0100
New York: - Christina Pagano, Pagano & Company Public Relations
+1 212-213-2851; +1 646-382-3871 (mobile); PaganoPRaol
Population Council
Melissa May, Director, Public Information +1 212 339 0525
Contact: Igor Gonda
Research Australia
View drug information on Estradiol Transdermal System; Evamist; Mirena.
Under the agreement, Acrux has a worldwide licence from the Population Council to intellectual property covering the use of Nestorone?® with Acrux's patented metered-dose skin spray delivery technology (MDTS?®). Acrux will develop and commercialise Nestorone?® MDTS?® and has the right to sub-license to commercial partners. In addition to commercial distribution of the product, Acrux (or its sub-licensees) will make Nestorone?® MDTS?® available at reduced prices to public sector organisations providing human reproductive health products to disadvantaged people.
Results of a Phase 1 clinical trial, conducted by Acrux last year under a development agreement with the Population Council, showed that a once daily application of Nestorone?® MDTS?® provides the level of Nestorone?® in the blood known to be effective for contraception. A Phase 2 trial, scheduled to start in the second half of 2006, aims to demonstrate that Nestorone?® MDTS?® controls ovulation. Acrux will seek commercial partners for the remaining steps in global commercialisation.
"This exciting product will give women a very attractive new option for contraception. It combines our unique technology with the know-how of one of the world's leading developers of reproductive health products," said Acrux CEO Igor Gonda.
"The target features of Nestorone?® MDTS?® are: a convenient daily spray onto the arm that is more discreet and less irritating to the skin than a patch, and we believe, will prove to have a better safety profile than other hormonal contraceptives. Market research has shown that many women will prefer the ease and convenience of this method to swallowing pills, taking injections, or wearing patches," he added.
Gonda also noted that Acrux sees great market potential for Nestorone?® MDTS?® given the fact that annual worldwide sales of hormonal contraceptives exceed US$4 billion, and sales of transdermal contraceptive patches in the United States alone are more than US$400 million a year.
Population Council CEO Peter Donaldson said he was pleased with the progress Acrux had made in the validation of its transdermal spray technology platform in clinical trials, especially in the area of women's health. "We are very encouraged by the results obtained so far with the Nestorone?® spray. An important part of the Population Council's mission is to meet the need for reproductive healthcare products on a global scale, and we believe that Acrux's technology can be an attractive option for many women around the world."
Acrux has two other products in its women's health portfolio that are delivered as daily sprays; Evamist for menopausal symptoms and Testosterone MDTS?® for decreased libido. Both are in advanced stages of development.
About Nestorone?® MDTS?®
Nestorone?®, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS?® is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug via the skin. The spray applicator is placed gently against the forearm and an actuator button is pushed. A light spray containing a proprietary formulation of Nestorone?® is quickly absorbed into the skin. Nestorone?® is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen. The spray is fast-drying, non-irritating, and invisible after application.
About Acrux
acrux.au/
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
Acrux's product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders and a contraceptive. 20 human clinical trials have been completed with 8 different drugs and the lead product, Evamist, is nearing the end of a phase 3 trial in the USA.
Acrux has licensed USA rights for Evamist (Estradiol MDTS?®) and Testosterone MDTS?® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS?® and Fentanyl UDTS to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.
About the Population Council popcouncil/
The Population Council, an international, non-profit, non-governmental organisation, seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Population Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of regional and country offices.
The Population Council has a proven track record in the successful development of female contraceptive products and has worked to make them accessible to people in developing countries. Three of the four major longacting reversible contraceptives available today were developed by the Population Council: the Copper T IUD, Norplant?®, Jadelle?®, and Mirena?®.
More than 50 million Copper T IUDs have been distributed in over 70 countries.
CONTACTS:
Acrux
USA: - Igor Gonda, CEO & Managing Director +61 439 811 339
Australia: - Jon Pilcher, CFO +61 3 8379 0100
New York: - Christina Pagano, Pagano & Company Public Relations
+1 212-213-2851; +1 646-382-3871 (mobile); PaganoPRaol
Population Council
Melissa May, Director, Public Information +1 212 339 0525
Contact: Igor Gonda
Research Australia
View drug information on Estradiol Transdermal System; Evamist; Mirena.
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