climbed Tuesday after the biopharmaceutical company announced positive top-line results from a phase III trial of NGX-4010, its dermal pain patch for patients with postherpetic neuralgia, or PHN, a frequent neuropathic pain condition affecting up to one in five shingles patients.
The company said the study met its primary endpoint of reducing pain for eight weeks, with a 32% reduction in pain from the baseline from a 60-minute application, compared with a 24% reduction in pain from the control group. The company said that all secondary endpoints were met as well, including significant results during weeks two through 12, and the initial safety analysis was consistent with the safety profile observed in a previous phase III study on the patch.
The non-narcotic patch contains synthetic Capscaicin, the active component of chili peppers, which is absorbed into the skin without significant absorption into the bloodstream. NeurogesX is also studying NGX-4010 in a second phase III trial on painful HIV-associated neuropathy (HIV-DSP), and top-line results from that study are expected in the first half of 2008.
The company plans to submit a new-drug application with the Food and Drug Administration in the second half of 2008 for treatment of both PHN and HIV-DSP. The patch has been granted orphan-drug status and fast-track designation from the FDA for HIV-DSP. NeurogesX said it's also on track to complete a filing for European regulatory approval in 2007 for a broad indication of peripheral neuropathic pain, including PHN, HIV-DSP and painful diabetic neuropathy (PDN).
Shares rose $1.32, or 18%, to $8.38 in recent trading Tuesday.
To watch CEO Anthony DiTonno discuss the pain patch in a June interview with TheStreet.com TV, click here.