“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 EpiCeptTM 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.