EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the targeted enrollment in a Phase IIb trial for EpiCept™ NP-1 in chemotherapy-induced peripheral neuropathy (CPN) has been attained. The trial is being conducted by National Cancer Institute (NCI)-funded Community Clinical Oncology Program. EpiCept™ NP-1 is a patented topical cream formulation of two FDA- approved drugs, 4% amitriptyline and 2% ketamine, and is intended to provide long-term relief from the pain of peripheral neuropathies. CPN may affect 50% of women undergoing treatment for breast cancer.

The double-blind, randomized placebo-controlled study has enrolled more than 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 neuropathy intensity scores from baseline to the endpoint. Secondary endpoints include the percentage of patients whose neuropathy intensity decreases at least 30% from baseline as well as various other measures. Topline data is expected to become available by year end.

About EpiCept™ NP-1

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. Peripheral neuropathies are 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).

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EpiCept Corporation