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Valeant taps Parexel to shepherd retigabine regulatory filings

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Valeant's planned mid-2008 NDA and MAA submissions for the anti-epileptic retigabine will be managed by Parexel. The contract services organization will "develop, coordinate and prepare" the NDA as well as the European MAA, Valeant says. Retigabine, a neuronal potassium-channel opener, is being studied in two international Phase III studies - RESTORE1 and RESTORE2 - as an adjunct treatment for partial onset seizures in patients with refractory epilepsy. Pharmaceutical Approvals Monthly erred in identifying the Phase III program in a previous story (1Pharmaceutical Approvals Monthly May 2007, p. 7). Valeant announced the initiation of a Phase IIa study of retigabine treatment of pain associated with post-herpetic neuralgia on May 31; the proof-of-concept study will enroll 180 patients...

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