Amitriptyline, ketamine combo NP-1 to treat neuralgia gets speedier review in US: EpiCept

 
NP-1, an experimental drug for the treatment of post-herpetic neuralgia, or PHN, has been granted orphan drug designation by US FDA.

NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

NP-1 is a patented formulation containing two FDA-approved drugs, amitriptyline, which is a widely-used antidepressant and ketamine, an NMDA antagonist that is used as an anesthetic.

US FDA assigns orphan drug designation to novel drugs or biologics that treat a condition affecting less than 200,000 Americans.

Orphan drug designation gives a seven-year period of U.S. marketing exclusivity from the date of marketing authorization and offers a number of incentives to the treatment developer.

EpiCept reported positive results from a 360-patient Phase IIb trial of NP-1. The data showed 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, or CPN, is currently being conducted in collaboration with the National Cancer Institute-funded Community Clinical Oncology Program, with results anticipated by the end of 2010.

“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,” stated Jack Talley, President and Chief Executive of EpiCept.

Orphan drug designation is likely to shorten the time required to file a New Drug Application with US FDA, obtain an approval to treat patients suffering from PHN and thereafter to help patients suffering from other forms of neuropathic pain, he added.

In September 2009, XenoPort Inc. and GlaxoSmithKline announced positive mid-stage trial results of their product candidate GSK1838262, or XP13512, for neuropathic pain associated with post-herpetic neuralgia in adults, which demonstrated statistically significant improvements over placebo on the primary endpoint at all doses.

PHN is a nerve pain, or neuralgia that persists after a shingles rash has cleared. If the pain goes, but then returns at a later date, this too is called PHN.

Shingles is an infection of a nerve, and causes a typical rash.

Shingles is caused by the varicella-zoster virus.

About one million people in the United States develop shingles each year, of these, nearly 15% develop PHN.