ED drug OK for patients taking nitrate medication

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.

Over 1,700 patients with mild to severe ED were enrolled in the two pivotal Phase III studies. The studies, conducted at 85 US research clinics, were randomised, double-blind, placebo-controlled, and were designed to confirm the efficacy and safety of Alprox-TD. Included in the enrollment were patients who had not previously taken ED medications and a significant number of very difficult to treat ED patients, including those with diabetes (21%) or prostatectomies (12%), as well as those who had little or no success with the currently approved oral ED medication (18%). 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 primary efficacy endpoints were the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF), the gold standard to measure primary efficacy endpoint. Success rates as assessed by the responses to question 2 (Were you able to insert your penis into your partner's vagina?) and question 3 (Did your erection last long enough for you to complete intercourse with ejaculation?) on the Sexual Encounter Profile questionnaire.

The results showed that all primary efficacy endpoints were highly significant (p=0.001 or p<0.001) compared with placebo.

The adverse events data presented showed no serious side effects attributed to Alprox-TD. Most side effects 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, chief of section of andrology and male infertility at Tulane University School of Medicine concluded by saying: 'Patients who cannot take or who do not respond to the currently approved oral ED medication may benefit from Alprox-TD.'

'The use of alprostadil is not contraindicted for patients who are taking nitrate medication for cardiovascular disease or any other type of medication.'

Dr James Yeager, senior vice-president for scientific affairs, said: 'Alprox-TD is the first patient-friendly alprostadil treatment which demonstrated significant efficacy in double blind, placebo controlled take-home studies in a broad patient population.'

'Even though the studies were not designed to examine the efficacy of our product in specific patient populations, we are nevertheless delighted with the results observed in the difficult to treat patient sub-groups, especially those patients.'