Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in Korea was a randomized, double-blind, placebo-controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. Following a 4-week non-drug baseline period, 240 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 25 mg, udenafil 50 mg or udenafil 75 mg. Patients took one tablet a day for 12 weeks with evaluations every 4 weeks. The primary efficacy endpoint was the change in the standard International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit. The secondary efficacy endpoints were the change from the baseline in the mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3. In addition a sub-group analysis was conducted to determine efficacy in the patients that had lower urinary tract symptoms associated with benign prostatic hyperplasia in addition to erectile dysfunction.
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In an advance that could one day enable surgeons to reconstruct and restore function to damaged or diseased penile tissue in humans, researchers at Wake Forest University Baptist Medical Center’s Institute for Regenerative Medicine have used tissue engineering techniques to completely replace penile erectile tissue in animals.

In the online early edition (Nov. 9-13) of the Proceedings of the National Academy of Sciences, the researchers report success using cells from rabbits to grow replacement penile erectile tissue for the animals in the laboratory. After implantation with the replacement tissue, the rabbits had normal sexual function and produced offspring. This is the most complete replacement of functional penile erectile tissue reported to date.
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Thousands of men are afflicted with an embarrassing and painful condition that triggers spontaneous, long-lasting erections. There are limited treatment options, but a solution could be on the way thanks to new research at The University of Texas Health Science Center at Houston.

Priapism is a condition of persistent painful penile erection in the absence of sexual desire. It is highly associated with sickle cell disease, leukemia and other blood disorders. It can also result from vasoactive drug abuse. One of the most dangerous complications seen in priapic patients is penile fibrosis, which can lead to erectile dysfunction. Priapism can be an urgent urological condition and causes of the erections lasting at least four hours are unknown.
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“The evidence is insufficient to compare the effectiveness or adverse effects of different PDE-5 inhibitors for the treatment of ED because there were only a few head-to-head trials,” explained the lead author of the guideline, Amir Qaseem, MD, PhD, MHA, FACP, senior medical associate at the American College of Physicians.

The guideline authors analyzed evidence gathered from 130 randomized controlled trials that evaluated oral PDE-5 inhibitors alone or combined. Treatment with a PDE-5 inhibitor resulted in statistically significant and clinically relevant improvements in sexual intercourse and erectile function in patients with ED, regardless of the cause (e.g., diabetes, depression, prostate cancer) or baseline severity.

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The American College of Physicians (ACP) has issued recommendations for the treatment of erectile dysfunction (ED). ACP, the nation’s largest medical specialty organization and second-largest physician group, strongly recommends that physicians initiate therapy with an oral phosphodiesterase type 5 (PDE-5) inhibitor in men who seek treatment for ED unless they have a contraindication to PDE-5 inhibitors, such as nitrate therapy.

As for which PDE-5 inhibitor to use, ACP recommends that physicians base the choice on the individual preferences of patients including ease of use, cost of medication, and adverse effects profile.
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Las Vegas-based Endogenous Stem Cells Activators Inc. (ESAI) announced that it will award a $1.3 million grant to Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LABioMed) for pre-clinical studies aimed at activating penile endogenous (adult) stem cells with the company’s drug, KRONOS IV. ESAI’s ultimate goal is the use of the drug to provide long-term correction of male erectile dysfunction in an aged population, as well as in patients with diabetes and those who have undergone prostatectomy for prostate cancer.
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Obese men are at increased risk for erectile dysfunction (ED), likely caused by atherosclerosis-related hypertension and cardiovascular disease, as well as hormonal changes associated with obesity, as described in a timely article published in Obesity and Weight Management, a journalzine published by Mary Ann Liebert, Inc. The article is available free online at http://www.liebertpub.com/owm

As many as 30-40% of men over the age of 50 may experience ED, and both obesity and physical inactivity may increase their risk. The build-up of atherosclerotic plaque in the arteries of obese men can damage the arterial lining and contribute to elevated blood pressure. In addition to atherosclerosis, the hormonal changes that accompany obesity, including lower testosterone, increase the risk of ED. The modifiable risk factors for heart disease, such as excess weight, diabetes, and hypertension, are generally the same as those for ED. Studies have shown that weight loss and increased physical activity can improve ED.
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Cutaneous application of nanoparticles may offer a new means of delivering drugs to treat erectile dysfunction (ED), according to findings presented at the 104th Annual Scientific Meeting of the American Urological Association (AUA). Topical treatments for ED may offer localized therapeutic results with the benefit of lower dosage and the avoidance of adverse side effects due to systemic absorption.

Researchers in New York investigated a novel hybrid hydrogel/glass nanoparticle platform. They developed nanoparticles capable of sustained release of therapeutic levels of nitric oxide (NO), which aids in erection biology and relaxes smooth muscle cells in the penis. Researchers applied these nanoparticles to the skin of the penis of seven rats, and measured erectile response by intracorporal pressure/blood pressure (ICP/BP) ratio. Of the seven animals treated with NO releasing nanoparticles, five experienced positive effects on the ICP/BC, resulting in a visible erection. The average time for an erectile response was approximately 65 minutes.
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An innovative drug-delivery system nanoparticles encapsulating nitric oxide or prescription drugs shows promise for topical treatment of erectile dysfunction (ED), according to a new study by scientists at Albert Einstein College of Medicine of Yeshiva University.

The new system, tested successfully on a small number of animals, could potentially prevent side effects associated with oral ED medications, if study results can be replicated in humans. That could mean safer and more effective ED therapy for millions of men with heart disease and other health problems affecting erectile function. The study is published today in the online edition of the more…

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN) announced preliminary results for its sexual dysfunction drug candidate, Zoraxel™, from a Phase IIa clinical study for the treatment of erectile dysfunction (ED). The double blind, randomized, placebo-controlled, dose ranging study found that human subjects treated with Zoraxel demonstrated improved erectile function as measured by changes over the International Index of Erectile Function (IIEF) baseline score within the 8-week treatment period.
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