EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept CorporationJan 27 2010

“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”

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced today that EpiCept^TM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a condition affecting less than 200,000 Americans. The designation offers a number of incentives to the treatment developer, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization. Funding for clinical studies, study design assistance, waiver of FDA user fees and tax credits are additional potential incentives.

“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,” remarked Jack Talley, President and Chief Executive Officer of EpiCept. “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 statistically significant pain relief compared with placebo and was equivalent in pain relief to the market leader 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.