EpiCept gets orphan drug designation from FDA
TARRYTOWN, N.Y. A topical treatment for post-herpetic neuralgia, more commonly known as shingles, has received an orphan drug designation from the Food and Drug Administration.
EpiCept Corp. announced Wednesday that the FDA had granted the designation to the drug, NP-1 (amitriptyline and ketamine). The FDA gives orphan drug designation to drugs that treat conditions affecting fewer than 200,000 Americans, offering incentives such as a market-exclusivity period of seven years rather than the five normally given to pharmaceutical drugs and potential funding for clinical studies, study design assistance and waiving of FDA user fees.
“NP-1’s orphan drug designation is another indication of the significant need that exists for new and more effective treatment options for PHN,” EpiCept president and CEO Jack Talley said. “Our recent phase 2b 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.”