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news.NeurogesX has achieved its endpoint in a phase III trial of its experimental skin patch in postherpetic neuralgia, a painful complication of shingles.
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The study evaluated the effect of a single application of NGX-4010, the company’s novel dermal patch, on pain due to postherpetic neuralgia (PHN). The primary endpoint in this phase III trial was achieved, demonstrating a statistically significant reduction in pain over an eight-week period. The reduction of pain was sustained over 12 weeks.
Lead trial investigator, Dr Misha-Miroslav Backonja, said: “We believe that NGX-4010’s unique profile has the potential to provide a meaningful therapeutic alternative to traditional therapies that need to be taken daily, most of which have systemic side effects.”
According to the Centers for Disease Control, there are approximately one million cases of shingles in the US each year, and approximate one in five shingles sufferers go on to develop PHN. People with PHN experience pain and increased sensitivity of the skin that can persist for many years.
NeurogesX plans to complete a confirmatory phase III trial in PHN in the second half of 2007 and expects to submit marketing applications to the European Medicines Agency in 2007 for European Union approval and to the FDA in 2008.