Positive data are being reported in Europe, where NeurogesX (San Carlos, California) intends to seek its first approval, from a Phase III trial of the company’s pain patch in treating postherpetic neuralgia.
The 402-patient study of NGX-4010 showed statistically significant pain relief vs. a control path over eight- and 12-week periods, the primary and secondary endpoints of the study. NGX-4010, previously called Transacin, is a high-concentration trans-capsaicin dermal patch.
Data from the Phase III study, which initially were reported in October, were to be presented today at the Second International Congress on Neuropathic Pain in Berlin.
The positive study in postherpetic neuralgia (PHN), along with a successful Phase III trial of the product in HIV-associated distal sensory polyneuropathy (HIV-DSP), will form the basis of a marketing authorization application expected to be filed in Europe later this year.
“We think this meeting in Berlin is an important milestone for us because it broadens our visibility beyond the United States,” Tony DiTonno, president and CEO of NeurogesX, told Medical Device Daily’s sister publication BioWorld Today. “This helps spread the academic awareness of where we stand clinically with this product.”
NeurogesX plans to seek a broader label of peripheral neuropathic pain in Europe. It intends to secure a marketing partner for Europe, and for other markets outside the U.S.
In the U.S., meanwhile, NeurogesX will need positive data from a second Phase III trial of NGX-4010 in PHN to support a new drug application. The design of that ongoing confirmatory trial is almost identical to the already-completed study, DiTonno said, the only difference being that some sites in Canada are included. Data from that study are expected in the second half of this year, with a new drug application anticipated in 2008, he said.
NeurogesX also is running a confirmatory study to support the positive result from the first Phase III trial in HIV-DSP. Data from that study are expected in the first half of next year.
The ongoing study — and the one reported in Berlin —compared NeurogesX’s 8% capsaicin patch to a patch containing 0.04 percent capsaicin, a quasi-placebo patch. Patients were allowed to remain on existing neuropathic pain medicines, with the instruction to take them in a consistent manner before and during the study period.
In the study, a single application of NGX-4010 demonstrating a statistically significant reduction in pain over an eight-week period: 29% for NGX-4010 vs. 19.9% for the control patch. The reduction of pain was sustained over 12 weeks: 29.9% for NGX-4010 vs. 20.4% for the control.
Trials have shown a single 30- or 60-minute administration of NGX-4010 may result in pain relief for up to 12 weeks. NGX-4010 is designed to work locally in the skin without significant absorption into the bloodstream.
PHN occurs in some patients following a shingles outbreak and the clearing of the subsequent rash. NeurogesX said there are about 1 million cases of shingles each year, with about 20% of them leading to postherpetic neuralgia.
NeurogesX is just coming out of the quiet period stemming from its $44 million initial public offering that priced early last month. The company sold 4 million shares at $11 per share. It had 12.5 million shares outstanding following the offering, with $13.9 million in cash of Dec. 31. The company’s net loss in 2006 was $30.1 million.
DiTonno said the company plans to provide updates on the ongoing confirmatory studies, as well as other developments, during its earnings call next week.