| Indication | Relief of pain associated with neuralgia due to diabetes (DPN), chemotherapy (CPN) or shingles in adults (PHN) |
| Target Population | 15+ million patients |
| Description | 4% amitriptyline and 2% ketamine cream |
| Dosage and Administration | 4 mL topical cream twice daily |
| Adverse Reactions | Mild sensitivity at application site |
| Experience | Over 660 patients treated in six clinical trials |
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EpiCept™ NP-1: Strong Phase II Efficacy Confirmed
Description
EpiCept NP-1 is a prescription topical analgesic cream designed to provide effective, long-term relief from the pain of peripheral neuropathies. Peripheral neuropathies are medical conditions caused by damage to the nerves in the peripheral nervous system. The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. It is estimated that these conditions affect more than 15 million people in the U.S. and is associated with conditions that injure peripheral nerves, including herpes zoster, or shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral neuropathies can also be caused by trauma or may result from surgical procedures. EpiCept NP-1 Cream is a patented formulation containing two FDA-approved drugs, amitriptyline (a widely-used antidepressant) and ketamine (an NMDA antagonist that is used as an anesthetic).
Stage of Development
Three clinical trials for EpiCept NP-1 are currently underway:
A Phase IIb trial in diabetic peripheral neuropathy (DPN). 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. Top-line results from the trial are expected in early 2008.
A Phase III trial in chemotherapy-induced peripheral neuropathy (CPN) is being conducted by the National Cancer Institute (NCI)-funded Community Clinical Oncology Program. The double-blind, randomized placebo-controlled study includes approximately 400 patients suffering from painful CPN for at least 28 days following the conclusion of chemotherapy. The primary endpoint of the 12-week trial is change in average daily pain intensity scores from baseline to the endpoint. This trial is currently enrolling patients.
A Phase IIb trial in peripheral herpetic neuropathy (PHN). This 500-patient, placebo- and active-controlled trial will compare the efficacy and safety of NP-1 vs. gabapentin and placebo. The primary endpoint for this trial is the change in pain intensity over the four-week duration of the trial. Preliminary results are expected early in the second quarter of 2008.