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Erectile Dysfunction
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my personal edition > erectile dysfunction > news
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Positive Phase 3 Results for Alprox-TD in Patients with Erectile Dysfunction: Presented at ICESD
ROBBINSVILLE, N.J. -- June 30, 2003 -- Combined analysis of two Phase III studies shows that Alprox-TD(R) achieved a statistically significant improvement in erectile function in men with erectile dysfunction.
Dr. Wayne Hellstrom, Chief of Section of Andrology and Male Infertility at Tulane University School of Medicine, presented the integrated data from the two Alprox-TD(R) pivotal Phase III studies here June 30th at the 2nd International Consultation on Erectile and Sexual Dysfunction.
Alprox-TD(R) is NexMed, Inc.'s proprietary cream treatment for erectile dysfunction (ED) and incorporates alprostadil with NexMed's patented NexACT(R) technology. Over 1,700 patients with mild to severe ED were enrolled in the two pivotal Phase 3 studies.
The studies, conducted at 85 US research clinics, were randomized, double-blind, placebo-controlled, and were designed to confirm the efficacy and safety of Alprox-TD(R).
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 pivotal Phase 3 studies showed that all three dose levels of Alprox-TD(R) 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 to placebo.
The adverse events data presented showed no serious side effects attributed to Alprox-TD(R). Most side effects were localized to the site of application and mild to moderate in nature. The overall discontinuance rate due to side effects was 3%.
Dr. Hellstrom concluded by saying, "Patients who cannot take or who do not respond to the currently approved oral ED medication may benefit from Alprox-TD(R)."
Dr. Hellstrom also said, "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 for NexMed, Inc., said, "Our Phase 3 data were well received by our colleagues at the Paris conference. Alprox-TD(R) is the first patient-friendly alprostadil treatment which demonstrated significant efficacy in double blind, placebo controlled take-home studies in a broad patient population."
Dr. Yeager added, "Even though the studies were not designed to examine the efficacy of our product in specific patient populations, we are nevertheless very delighted with the results observed in the difficult to treat patient subgroups, especially those patients who cannot take, or who have had little or no success with the currently approved oral ED medication."
SOURCE: NexMed, Inc.
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