Positive results for Alprox-TD for ED
Alprox-TD, which is NexMed's proprietary cream treatment for erectile dysfunction (ED) and incorporates alprostadil with NexMed's patented NexACT technology, has been shown to have a positive effect in recent Phase III studies.
More than 1,700 patients with mild to severe ED were enrolled in the two pivotal Phase III studies. The studies were randomised, double-blind and placebo-controlled, and were designed to confirm the efficacy and safety of Alprox-TD. Included in the enrolment were patients who had not previously taken ED medications and a significant number of very difficult to treat ED patients, including those with diabetes or prostatectomies, as well as those who had little or no success with the currently approved oral ED medication. Many of these patients also had hypertension and cardiac disease.
The combined analysis of the two studies showed that all three dose levels of Alprox-TD achieved a statistically significant improvement in erectile function as measured by three primary efficacy endpoints.
The adverse events data presented showed no serious side-effects attributed to Alprox-TD. Most were localised to the site of application and mild to moderate in nature. The overall discontinuance rate due to side effects was 3%.
Dr Wayne Hellstrom, from Tulane University, said: 'The use of alprostadil is not contraindicated for patients who are taking nitrate medication for cardiovascular disease or any other type of medication.'