At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC (”Plethora” AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE). Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo. Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.
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The findings, now available online in the Nov. 15 issue of The Journal of Infectious Diseases, suggest HAART regimens should be initiated as early as possible in eligible mothers in areas with limited resources, such as Africa, where most infant HIV-1 infections occur, and breastfeeding is common.

Led by Taha E. Taha, MBBS, PhD, of Johns Hopkins University Bloomberg School of Public Health, the researchers studied 2,318 infant/mother pairs in Malawi; a total of 130 infants (about 6 percent) became HIV-1-infected. The protective effect of HAART was readily apparent: The therapy was associated with an 82 percent reduction in postnatal HIV-1 transmission. The reduction was observed in mothers with CD4 counts low enough to be eligible for HAART compared to mothers with low counts who did not receive the therapy. Among the infants who became HIV-1-infected, only five had mothers who were both eligible for HAART and actually received it, representing a transmission rate of 1.8 percent. In contrast, 53 infected infants had mothers who were HAART-eligible but who went untreated (a 10.6 percent transmission rate). Seventy-two other infected infants had mothers who were HAART-ineligible because their CD4 cell counts were consistently high (a 3.7 percent transmission rate).

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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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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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Sciele Pharma, Inc. a Shiongi Company, and Plethora Solutions Holdings PLC (”Plethora” – AME:PLE) today presented highly encouraging results from a European Phase III randomized, double-blind, placebo-controlled study of PSD502 for the treatment of premature ejaculation (PE). In this study, men treated with PSD502 five minutes before intercourse were able to delay ejaculation up to six times longer than those who used a placebo. Additionally, patients and their partners reported significant improvements in overall sexual satisfaction scores when using PSD502. The results were presented today at the American Urological Association Annual Meeting.
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A long-term study by researchers at UCLA’s Jonsson Comprehensive Cancer Center found that the three most common treatments for localized prostate cancer had significant impacts on patients’ quality of life, a finding that could help guide doctors and patients in making treatment decisions.

The four-year study, which followed 475 men treated for early stage prostate cancer, also resulted in the development of “probability plots,” gauges which can be used to predict when treatment side effects such as urinary incontinence, sexual dysfunction or bowel problems might return to normal, or whether the patient will ever fully recover. Such predictions could be used to determine whether further treatments or surgeries are needed to deal with adverse side effects, said Dr. John Gore, an urologist and the study’s first author.
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UroToday.com – This updated review of tadalafil (Cialis), one of the three available phosphodiesterase type 5 (PDE5) inhibitors that revolutionized the treatment of erectile dysfunction (ED), analyzes its latest clinical studies. Tadalafil’s most unique and identifying characteristic is its long half-life of 17.5 hours, compared with 4 hours for sildenafil (Viagra) and vardenafil (Levitra).

We have known since 2003 that this longer half-life provides a therapeutic window of 36 hours.1 Recently, studies have shown that tadalafil’s longer half-life lends itself to once-daily dosing as well. 2-7 Steady-state plasma concentrations are attained within five days of initiating daily dosing. 8 Based on its pharmacokinetics, after five days of once-daily dosing, the plasma concentration of tadalafil achieved with a 2.5 mg and 5 mg daily dose is 4 mg and 8 mg, respectively.
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