Valeant Reports Preliminary Results From Phase IIa Retigabine Study

Valeant has reported preliminary results from its phase IIa proof-of-concept clinical trial of retigabine, for the treatment of pain associated with postherpetic neuralgia (PHN).

Reportedly, retigabine was generally well tolerated, the study did not meet its pre-specified primary efficacy endpoint.

The study was a randomized, double-blind, placebo-controlled phase IIa proof-of-concept study, with 187 patients randomized 2:1 of retigabine versus placebo for a treatment period of up to ten weeks.

In the study, the patients were treated to their individually determined maximum tolerated dose within the range of 300mg to 900mg per day.

The company said that the primary outcome assessment was the comparison of the average pain intensity over the last seven days of maintenance therapy, with retigabine versus placebo.

Michael Pearson, chairman and CEO of Valeant, said: As is typical in many proof-of-concept studies, these results are inconclusive at this time with regard to the potential utility of retigabine in PHN patients.

The treatment duration was relatively short and with limited statistical powering for the study overall. There are many additional analyses that have yet to be undertaken and these will be performed over the next several months. Moreover, given that the provisional results from this study will not impact the submission of our New Drug Application for retigabine in epilepsy, we remain focused on the submission as our number one priority, he added.