Solucion impotencia

Australian company, Acrux, announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

AXIRON™ is applied to the underarm using a unique “notouch” applicator. Upon approval, AXIRON™ would be the first and only pharmaceutical product applied to the armpit in much the same way as an antiperspirant. As well as existing patents that protect AXIRON™ to 2017, Acrux has a new patent that, when granted, will extend protection of this novel, classleading feature until 2026.

Phase III trial results

The trial met its primary endpoint by demonstrating that after four months of treatment with AXIRON™, 84 percent of subjects achieved average blood levels of testosterone within the normal range, exceeding the requirement of 75 percent that was agreed upon by the U.S. Food and Drug Administration (FDA).

After only two weeks of treatment, it was found that 76 percent of subjects had average blood levels of testosterone within the normal range.

The average testosterone level for the responder group after 120 days treatment with AXIRON™ was 504ng/dl (the normal range being 3001,050ng/dl). The average baseline testosterone level in subjects prior to treatment was 190ng/dl.

Four different dose levels of AXIRON™ were tested, and the trial demonstrated that the optimum dose for 75 percent of subjects was 60mg testosterone per day, equivalent to one single application of AXIRON™ to each armpit.

Subjects were permitted to use an underarm deodorant or antiperspirant during the trial. More than half of the men continued to apply an underarm deodorant or antiperspirant as part of their daily routine, and an analysis of these subgroups showed that this had no impact on the efficacy of AXIRON™ treatment.

Analysis of mood, sexual desire, sexual activity and sexual performance before and after four months of treatment showed significant improvement from baseline across all measures.

There were no serious adverse events related to treatment with AXIRON™ and no adverse trends were identified with the biochemical safety measures, including prostate specific antigen, haematocrit, and the ratio of dihydrotestosterone to testosterone.

Fiftytwo men continued treatment for an additional two months specifically to monitor skin safety with six months of continuous use. Eight subjects reported some form of transient application site reaction during the main treatment phase of four months; however, these reported events were all mild or moderate and resolved quickly without any intervention. No patient withdrew due to a skin reaction.

“In terms of the proportion of responders to testosterone replacement using AXIRON™, the pharmacokinetic parameters and the response from this multicenter clinical trial, the results are very exciting and precisely what we had hoped to see,” commented lead investigator Professor Christina Wang, MD, at Los Angeles Biomedical Research Institute and Professor of Medicine at David Geffen School of Medicine at UCLA. “The posttreatment changes demonstrated positive responses in sexual desire, sexual activity, mood and general wellbeing, underpinning the patient reported benefits of this treatment. Patient compliance and acceptance of the unique notouch axilla application technique was very good, as evidenced by the high completer rate,” added Professor Wang.

Earlier this month, Acrux announced it had held a preNDA meeting with the FDA in Washington, DC and the FDA had agreed Acrux may proceed to file a New Drug Application (NDA) in the United States, which Acrux is targeting for the end of 2009.

Acrux has already received strong interest from a number of potential marketing partners for AXIRON™. Following release of the Phase III trial results, formal partnering discussions with interested parties will be progressed in October 2009.

If approved by the FDA, market entry for AXIRON™ could occur in early 2011, and may play an important role in the treatment of patients living with hypogonadism. Based on IMS data, global sales in this market for the year to March 2009 exceeded U.S. $1 billion for the first time, and sales in the U.S. market grew by more than 20 percent. Sales of testosterone gels in the U.S. grew to U.S. $0.7 billion for the year to March 2009.

Last year Acrux published results from market research conducted in both patients and physicians in the USA, in which two thirds of patients confirmed that they would prefer AXIRON™ to their existing gel treatment and 87 percent of physicians said that they would offer AXIRON™ to their patients that currently use gels. Importantly, 94 percent of patients who tried AXIRON™ rated it better than the testosterone gels in its ability to reduce the risk of transference of testosterone to others. In addition, 92 percent of physicians surveyed who prescribe gels as first line therapy rated AXIRON™ as very good or excellent in its ability to reduce the risk of transference to others when compared to the gels.

“We are excited by the AXIRON™ Phase III trial results and are now well positioned to submit our NDA by the end of 2009,” said Dr. Richard Treagus, CEO and Managing Director of Acrux. “These results, along with our recent meeting with the FDA, place us in a strong position as we initiate a process to select marketing partners for what is a unique testosterone delivery system that we believe will be a patient preferred treatment for hypogonadal men,” he said.

About AXIRON™ (testosterone solution) 2%

Testosterone deficiency in men (hypogonadism) is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. Estimates of men over 50 years of age having testosterone levels below the normal healthy range vary from 10 percent to 39 percent1. However, in the majority of men this remains undiagnosed, with only around five percent to 10 percent of those with the condition receiving treatment. With a high incidence rate and low but growing treatment rates, the male testosterone deficiency market will remain an attractive commercial opportunity. AXIRON™ has been designed to overcome the significant issues and drawbacks associated with the current gel treatments. Large volumes of gel are applied by hand and rubbed on to the abdomen, shoulders or arms. They are considered messy, sticky, slowdrying and may have an unpleasant odour to some patients. One of the biggest drawbacks is the risk of transference to other people through contact with the application site or from residue left on the hands following application. AXIRON™ is a fasterdrying and pleasant smelling solution that is applied to the armpits once daily, using a convenient and ergonomic “notouch” applicator designed in Australia. The armpit is a unique application site for transdermal drug delivery and it offers significant advantages to the patient in terms of convenience and may have a lower risk of transference from patient to others. A factsheet on AXIRON™ is available for download at acrux.com.au.

1 Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years the HIM study. Int J Clin Pract. 2006;60(7)762769

Deborah Kotz writes in the U.S. News & World Report blog “On Women” that the debate surrounding whether CDC will recommend newborn male circumcision as part of an effort to curb the spread of HIV is “complex.” According to the blog, “Circumcision is not just a medical procedure but a religious and cultural one,” and “[i]n terms of the science, its not clear how much circumcision will protect American men from being infected with HIV, where the virus is largely transmitted through homosexual contact.” In addition, there is “potential here for the spreading of misinformation,” she writes, concluding, “… CDC folks will have to evaluate the latest research carefully before deciding to take a cultural practice and turn it into a public health mission” (8/31).

This information was reprinted from dailyreports.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily U.S. HIV/AIDS Report, search the archives and sign up for email delivery at dailyreports.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Black gay men have less choice when it comes to sexual partners than other groups and, as a result, their sexual networks are closely knit. These tightly interconnected networks make the rapid spread of HIV more likely. In a study1) looking at social and sexual mixing between ethnic groups in men who have sex with men, H. Fisher Raymond and Willi McFarland, from the San Francisco Department of Public Health in the US, show that social barriers faced by Black gay men may have a serious impact on their health and wellbeing. Their findings are published in Springers journal AIDS and Behavior.

In the US, there is a disproportionate burden of HIV infection in Black Americans, who accounted for nearly half of all HIV/AIDS cases diagnosed in 2006 four times the national average. Raymond and McFarlands research looks at the current levels of sexual mixing between racial and ethnic groups of men who have sex with men in San Francisco, and identifies reasons that underlie these sexual mixing patterns.

A total of 1,142 gay men took part in computerassisted interviews. They were asked about their own ethnicity, the race of their sexual partners in the last six months, their perception of how easy it is to meet sexual partners of different ethnicities, where they meet sexual partners, their view of HIV infection risk and the predominant race of their network of friends.

Black gay men are the least preferred of sexual partners by other races. Black men are perceived to be riskier to have sex with, which can lead to men of other races avoiding Black men as sexual partners. They are also perceived as less welcome in the common social venues of gay men in San Francisco. As a result, Black men are three times more likely to have sexual partners that are also Black, than would be expected by chance alone.

In the authors view, the combination of attitudes on the part of nonBlack gay men, friendships and social networks that are less likely to include Blacks, and the environments found in gay venues serve to separate Black gay men from other groups. Consequently, the sexual networks of Blacks are pushed to be more highly interconnected than other groups, with the potential for a more rapid spread of HIV and a higher sustained prevalence of infection among Black gay men.

The authors conclude “The racial disparity in HIV observed for more than a decade will not disappear until the challenges posed by a legacy of racism towards Blacks in the US are addressed.”

The study is available online free of charge on Springers information platform SpringerLink at dx.doi.org/10.1007/s1046100995746

Reference
1. Raymond HF & McFarland W (2009). Racial mixing and HIV risk among men who have sex with men. AIDS and Behavior; DOI 10.1007/s1046100995746

Source
Joan Robinson

Dry eye disease is common among American men older than 50 and increases with age, high blood pressure, benign prostate disease and the use of antidepressants, according to a report in the June issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

Dry eye is one of the most common eye diseases and reason that older adults seek eye care, according to background information in the article. “It is an important public health problem, causing increased risk of ocular infections and bothersome symptoms of ocular discomfort, fatigue and visual disturbance that interfere with crucial activities such as reading, working on a computer and driving a car,” the authors write.

Debra A. Schaumberg, Sc.D., O.D., M.P.H., of Brigham and Womens Hospital and Harvard Medical School, Boston, and colleagues estimated the prevalence of and examined risk factors for dry eye disease among 25,444 U.S. men who participated in the Physicians Health Study I and II. The men were asked if they had ever been diagnosed with dry eye disease and also whether they had symptoms, including dry or irritated eyes.

Overall, 765 men (3 percent) reported being diagnosed with dry eye, 6.8 percent experienced at least one symptom (dryness or irritation) constantly or often and 2.2 percent reported both symptoms constantly or often. The total agestandardized prevalence of dry eye disease among men 50 and older was estimated to be 4.34 percent. Men 75 years and older were more likely to have the conditionprevalence increased from 3.9 percent among men age 50 to 54 to 7.7 percent among men age 80 and older. High blood pressure, benign prostatic hyperplasia (a noncancerous enlargement of the prostate) and the use of medications to treat depression, hypertension or hyperplasia were also associated with an increased risk of dry eye disease.

“The present study estimates that approximately 1.68 million men 50 years and older are affected with dry eye disease in the United States,” the authors write. “These data, derived from studying more than 25,000 men, show a significantly lower prevalence of dry eye disease than was found in a similar study using the same methods in U.S. women, among whom the prevalence was estimated at 3.23 million women. Nonetheless, there is a significant increase in the prevalence of dry eye disease with age among men, as is the case among women, and there is a predicted growth to 2.79 million U.S. men affected by dry eye disease in 2030.”

“Given the increasing recognition of the adverse visual impact of dry eye disease, and the high level of bother patients report because of its irritative symptoms, we hope that these data from a large and wellcharacterized group of U.S. men will provide further motivation for clinicians and researchers to understand this disease and develop more effective and targeted interventions for patients,” they conclude.

Arch Ophthalmol. 2009;127[6]763768.