Jack Talley, president and chief executive officer of EpiCept, said: “NP-1’s orphan drug designation is another indication of the significant need that exists for new and more effective treatment options for patients suffering from PHN. Our recent Phase IIb study of NP-1 in the PHN indication demonstrated that it has at least equivalent efficacy to the unit market leader, gabapentin, which we believe is a strong indicator of its future clinical and commercial potential.
“We believe this orphan drug designation is likely to shorten the time required to file a New Drug Application with the FDA, obtain an approval to treat patients suffering from PHN and thereafter to help patients suffering from other forms of neuropathic pain.”
In January 2009, EpiCept reported positive results from a 360-patient phase IIb trial of NP-1 in patients with PHN. In this trial, NP-1 achieved more relief from pain compared to placebo and was equivalent in pain relief to Gabapentin. A trial in chemotherapy-induced peripheral neuropathy (CPN) is currently being conducted in collaboration with the National Cancer Institute (NCI)-funded Community Clinical Oncology Program. The results are anticipated by the end of 2010.
EpiCept NP-1 is a prescription topical analgesic cream designed to provide effective, long-term relief from the pain of peripheral neuropathies. EpiCept NP-1 Cream is a patented formulation containing two FDA-approved drugs, Amitriptyline and Ketamine.