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news.EpiCept, a specialty pharmaceutical company, has announced positive results from its Phase IIb randomized, double-blind, placebo-controlled non-inferiority trial of its prescription topical analgesic EpiCept NP-1 Cream in post-herpetic neuralgia. The trial met its primary endpoints and demonstrated a favorable safety profile compared with gabapentin.
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The 360 patient, active comparator trial compared the efficacy and safety of NP-1 against both gabapentin and placebo. The first primary endpoint was the change in pain intensity over the four-week duration of the trial. The data demonstrated that NP-1 achieved statistically significant superior efficacy compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that NP-1 was not inferior to gabapentin in reducing pain, was also met.
A key secondary endpoint measured in the trial from a responder analysis indicated that 63% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo arm (p=0.033). Top-line data results further indicate that NP-1 achieved a superior safety profile when compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the reporting of adverse events.
The post-herpetic neuralgia trial is one of three trials recently completed or currently ongoing that is studying the effects of NP-1 on various indications within peripheral neuropathy and which are intended to broaden NP-1’s potential labeling for the treatment of peripheral neuropathies.
Jack Talley, president and CEO of EpiCept, said: These positive data further demonstrate the significant potential of NP-1 to provide long-term relief to patients affected by the pain of peripheral neuropathies, a condition which afflicts more than 15 million people in the US alone. We expect these highly positive results will facilitate our efforts to find an attractive partner to help conduct the Phase III trials for NP-1.