Valeant's retigabine enters Ph II PHN trial

The USA's Valeant Pharmaceuticals has enrolled the first patient in a Phase II clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia, a painful and common complication of shingles.

The randomized, double-blind, placebo-controlled proof-of-concept study is designed to enroll a total of 180 patients with 120 subjects randomized to retigabine and 60 to placebo for a period of up to 10 weeks. Study patients will be titrated to their individually-determined maximum-tolerated dose within the range of 300mg to 900mg per day. The primary outcome assessment will be the comparison of the average pain intensity over the last seven days of maintenance therapy with retigabine versus placebo, as measured on a standard 0-10 numerical rating scale.

According to IMS Health Data, the global market for antiepileptic drugs is $13.6 billion on a moving annual total basis. The market includes mulitple indications ranging from epilepsy to pain, migraine and mood disorders.