Jun 16 2008

NexMed Confirms FDA Acceptance Of NDA For Erectle Dysfunction Product

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NexMed, Inc. (Nasdaq: NEXM), a developer of innovative transdermal products based on its proprietary NexACT® drug delivery technology, announced that the New Drug Application (NDA) filed by the Company for its erectile dysfunction (ED) product, a topically applied alprostadil cream, was accepted for review by the U.S. Food and Drug Administration (FDA).
"We are pleased to announce the FDA’s acceptance of our submission for our ED product," stated Vivian Liu, President and Chief Executive Officer of NexMed. "generishe cialis online kaufen mastercard We have already begun working with the agency and with our partner, Warner Chilcott, and look forward to gaining regulatory approval for this important new therapy. I am confident in Warner Chilcott’s CEO Roger Boissonneault and his team’s ability to establish a major presence in urology. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product, upon its approval."
The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of eight months, should the FDA not require any additional studies or information.
About NexMed
NexMed, Inc. is leveraging its proprietary NexACT® drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs. NexMed’s novel, onychomycosis treatment, licensed to Novartis, is currently in pivotal Phase 3 trials in the U.S. and Europe. NexMed’s pipeline also includes a Phase 2 treatment for female sexual arousal disorder and an early stage treatment for psoriasis. For further information about the Company, go to
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to whether and when the FDA will approve the Company’s ED Product.
NexMed
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Jun 16 2008

Teaching Patients To Use Their Penile Prosthesis Requires Compassion

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While penile prosthesis devices are the most invasive and least chosen treatments for erectile dysfunction (ED), the devices garner the highest patient satisfaction rates. In the April 2008 issue of Urologic Nursing, Annette Liechty and Susanne A. Quallich review a teaching process that nurses can use to show a patient to successfully operate the device.
Liechty and Quallich say the single most important aspect of teaching patients to use their penile prosthesis is ensuring the patient is comfortable with and physically able to operate the device. Patients are generally very motivated to operate the device, say the authors, as it allows for spontaneity in sexual relationships, unavailable before the prosthesis surgery.
The authors acknowledge adults learn in different ways and encourage health care providers to use an appropriate style (verbal, written or demonstration) when teaching patients to use the device. Kaufen generishe cialis Liechty and Quallich say addressing these issues in a compassionate and professional manner can help patients achieve a satisfactory degree of sexual functioning.
"Teaching a Patient to Successfully Operate a Penile Prosthesis"
Annette Liechty, LPN, CUA; Susanne A. Quallich, APRN, BC, NP-C, CUNP
Urologic Nursing; April 2008; www.suna.org
About SUNA (Society of Urologic Nurses and Associates)
The Society of Urologic Nurses and Associates is a national, non-profit professional membership association with over 3,000 members and annual revenues of $1.5 million. SUNA derives its income from membership dues ($60), conference registration fees, exhibits, advertising, grants, and the sale of educational products.
SUNA publishes a professional, peer-reviewed bi-monthly journal (Urologic Nursing Journal) and a bi-monthly newsletter (Uro-Gram). SUNA establishes the scope and standards of urologic nursing practice and the scope and standards of advanced urologic nursing practice. SUNA provides scholarships, grants and awards to deserving nurses and other health care professionals. SUNA supports and promotes the certification of urologic nurses and associates by providing educational preparation for the examinations offered which lead to certification in three areas. SUNA provides a variety of opportunities for participation including local chapters, task forces and Special Interest Groups (SIGS) in five major subspecialty areas.
www.suna.org
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Jun 16 2008

High Levels Of The Molecule Adenosine Linked To Priapism

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Jun 16 2008

Scientists cast doubt on value of screening for prostate cancer

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Men’s Health News
Even though deaths from prostate cancer death have fallen in the U.S. since screening became more common, new research is suggesting that this does not justify the need for such tests.
According to a team of scientists from the University of Bristol many other factors could be involved such as different treatment programmes for American men and some discrepancy over how deaths are reported.
Since screening became widespread in the U.S. mortality rates have fallen four times more than in the UK.
It seems that many men over 80 have evidence of prostate cancer when they die, but it is often unclear whether this or other conditions killed them, which leads to different accounts on death certificates.
The researchers say this does not mean that screening by using a blood test to detect what is known as the prostate specific antigen (PSA), is not saving lives.
But they suggest until research pins down the exact role of screening in decreasing prostate cancer mortality, it remains a matter of speculation.
Whereas prostate cancer screening became common in the States in the early 1990s, and nearly 60% of men over 50 were being tested by 2001, in the UK, between 1999 and 2002, an estimated 6% of men aged 45-84 had been tested.
At the start of the 90s, mortality rates for the two countries were similar, but after this period, the rate of decline in the U.S. at 4.17% per year, was almost four times that of the UK, at 1.17% per year.
Simon Collin a statistician who led the research says other changes were occurring in the treatment of men with prostate cancer in the U.S. during that time and included the use of a particular hormone treatment in older men and more aggressive treatment of those with an advanced form of the disease.
Prostate cancer accounts for a quarter of cancers in men but the National Health Service (NHS) has resisted offering widespread PSA screening because the test is seen as notoriously inaccurate.
Even though 10-15% of men will have high enough PSA levels to justify carrying out a prostate biopsy, only 2-3% will require any treatment.
This means in fact that the majority will have been subjected to unpleasant, invasive and potentially costly investigations for no reason with possible serious side effects such as impotence and incontinence.
Experts say there is an urgent need for a new diagnostic test which could form part of a national screening programme and which would reliably identify the aggressive prostate cancers that need treatment.
Buy diflucan without prescription The NHS says all screening programmes are based on an assessment that more good than harm will be achieved through their implementation and until there is clear clinical evidence to show real benefit can be gained from routine prostate screening, the NHS will not be screening men who have no symptoms for prostate cancer.
The authors of the study say while the differing outcomes are worrying, the jury is still out on whether screening is worthwhile.
The research is published in Lancet Oncology.
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Jun 16 2008

Low Testosterone May Cause Health Problems That Lead To Erectile Dysfunction

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Men with erectile dysfunction should be examined for testosterone deficiency and the metabolic syndrome, because these conditions commonly occur together, a new study shows. The results will be presented at The Endocrine Society’s 90th Annual Meeting in San Francisco.
"Erectile dysfunction is a portal into men’s health," said the study’s senior author, Aksam Yassin, MD, PhD, of the Clinic for Urology and Andrology of the Segeberger Clinics in Norderstedt, Germany. "It is becoming clear that obesity, diabetes, high blood pressure, cholesterol problems and erectile difficulties are intertwined, and a common denominator is testosterone deficiency."
Yassin’s research, performed with scientists from The Netherlands, Germany and the United Arab Emirates, aimed to determine in men with erectile dysfunction (ED) the prevalence of hypogonadism, the scientific term for testosterone deficiency.
Over a two-year period the investigators studied 771 patients who sought treatment for ED. Their average age was 56. The patients received a comprehensive screening for low testosterone and indicators of the metabolic syndrome, a cluster of risk factors that increase the chances of developing heart and vascular disease and type 2 diabetes. Having three of the following five risk factors establishes the diagnosis of this syndrome: increased waist circumference (abdominal fat), low HDL ("good") cholesterol, high triglycerides (fats in the blood), high blood pressure, and high blood sugar.
Among the 771 men, 18.3 percent of the men (141 men) had testosterone deficiency, which had previously been undetected, the authors found. The prevalence of hypogonadism in the general population of men age 45 and older is about 12 percent, Yassin said.
Of all the men in the study, 270 (35 percent) had type 1 or type 2 diabetes; in eight of the men, diabetes was a new diagnosis, according to study data. High blood pressure was found in 239 men (31 percent), and 12 of these men had been unaware of it. Among the 162 men (21 percent) who had dyslipidemia abnormal cholesterol or triglycerides nine of them had not previously been diagnosed. And 108 men, or 14 percent, had varying degrees of coronary heart disease. Five of them received this diagnosis for the first time, Yassin said.
Men with ED especially older men should therefore receive evaluation not only for ED but also for testosterone deficiency and any underlying signs of the metabolic syndrome, he advised.
Yassin disclosed that he is on the speakers’ bureau for Bayer Schering, which makes a brand of testosterone.
Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. kaufen cialis soft Ohne Rezept To learn more about the Society, and the field of endocrinology, visit our web site at
Endocrine Society
8401 Connecticut Ave., Ste 900
Chevy Chase, MD 20815
United States

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