| 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 850 patients treated in seven 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. these conditions are caused from injured peripheral nerves, following 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).
A four-week, Phase IIb 200- patient trial in diabetic peripheral neuropathy (DPN) has been performed (Neuracept) in this type of neuropathic pain. The Neuracept trial was a double blind, placebo-controlled study of NP-1 in 215 DPN patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between NP-1 and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715). Key secondary endpoints measured in the trial indicate that 60% of patients in the NP-1 treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain scores measured trended in favor of the NP-1 treated patients over the placebo group, indicative of an analgesic effect. The preliminary data derived from the trial support the continued study of NP-1 in a late-stage pivotal clinical trial.
A four-week, Phase IIb, 360- patient trial in post-herpetic neuralgia (PHN) has been performed. The trial compared the efficacy and safety of NP-1 against both gabapentin and placebo. 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). 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.
Stage of Development
One clinical trial for EpiCept NP-1 is currently underway:
A Phase II 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 6-week trial is change in average daily pain intensity scores from baseline to the endpoint. This trial is currently enrolling patients.