Fast acting erectile disorder drug goes on trial againFebruary 16th, 2009 - 12:41 pm ICT by IANS
Washington, Feb 16 (IANS) A new fast-acting oral drug for erectile dysfunction (ED) is ready for a crucial trial phase.
It’s going to be a multicentre, randomised, double-blind, placebo-controlled trial that will evaluate the safety and efficacy of Avanafil in the treatment of ED in men with type-1 or type-2 diabetes.
“There has not been a new treatment option for men with ED in more than five years,” stated Andrew McCullough, associate professor of clinical urology, New York University (NYU) School of Medicine and the study’s clinical investigator.
“Early data suggest that Avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options,” he added.
This study will enrol approximately 375 patients at about 30 locations in the US. Subjects are instructed to attempt sexual intercourse 30 minutes after taking Avanafil, with no restrictions on food or alcohol consumption.
Erectile dysfunction, or ED, the inability to attain or maintain an erection sufficient for intercourse, was reported by 35 percent of men aged between 40 and 70 years in the US.
Subjects who meet the inclusion criteria will undergo a four-week non-treatment run-in period followed by 12 weeks of treatment.
Diabetes is one of the most common causes of ED; clinical data suggest that at least 50 percent of diabetic men will experience difficulties with erectile function. Diabetic men are up to three times more likely to have ED than non-diabetic men.
“Evidence suggests that there is room for significant improvement in the current treatment of ED,” said Charles Bowden, senior director, clinical development, VIVUS, which is developing the drug.
“We’re pleased with the promising results demonstrated thus far with Avanafil, and with the momentum behind our Phase III programme. Enrolment in our first pivotal study, REVIVE, initiated in December to evaluate Avanafil in ED, is ongoing. REVIVE-Diabetes will be conducted at many of the same sites as REVIVE.”
VIVUS previously reported positive results from the Phase 2 studies of Avanafil. Following a four-week, non-treatment, run-in period, 284 patients were treated for 12 weeks with placebo or Avanafil at various doses.
The primary endpoints used to assess treatment efficacy included the percentage of erections sufficient for vaginal penetration and the percentage of erections lasting long enough for successful intercourse.
Avanafil produced erections sufficient for vaginal penetration on 76, 79, 80 and 84 percent of sexual attempts on the 50, 100, 200 and 300 mg doses, respectively, said a VIVUS release.
Erections lasting long enough for successful intercourse were achieved on 54, 59, 62 and 64 percent of attempts, respectively.
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Tags: alcohol consumption, andrew mccullough, avanafil, causes of ed, charles bowden, clinical investigator, clinical urology, controlled trial, diabetic men, double blind placebo, inclusion criteria, new york university, nyu school of medicine, oral drug, pivotal study, promising results, sexual intercourse, trial phase, type 2 diabetes, vivus