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news.EpiCept has completed patient enrollment in the Phase IIb 'Neuracept' trial for EpiCept NP-1, a patented topical cream formulation of two FDA- approved drugs, 4% amitriptyline and 2% ketamine, which is intended to provide long-term relief from the pain of peripheral neuropathies.
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This Phase IIb trial compares the active ingredients in NP-1 against placebo in patients suffering from diabetic peripheral neuropathy (DPN), the most common form of neuropathic pain. The four-week, 200- patient trial is intended to confirm and expand upon earlier work that provided a preliminary efficacy signal in this type of neuropathic pain. The primary endpoint for the Phase IIb trial is the difference between active and placebo changes in pain intensity from baseline compared to the average over the last seven days of treatment.
Jack Talley, president and CEO of EpiCept, said: “We believe that NP-1 has the potential to become a new and efficacious topical treatment without the inherent systemic side effects of alternative treatments for the 15 million Americans who suffer from peripheral neuropathies. We expect to report top-line results from this trial in early 2008.”