FDAnews
www.fdanews.com/articles/101557-neurodiscovery-updates-nsl-043-phase-i-development-plans

NeuroDiscovery Updates NSL-043 Phase I Development Plans

November 28, 2007

Australia’s NeuroDiscovery reported on its Phase I development program for NSL-043, a treatment for neuropathic pain.

NSL-043 is being developed by NeuroDiscovery and its subsidiary NeuroSolutions under an agreement with Japan’s Sosei.

NeuroDiscovery has begun a double-blind, placebo-controlled, multiple-dose, sequential-group, dose-escalation trial in healthy male volunteers to assess the safety, tolerability and pharmacokinetic profile of the drug administered as an oral capsule.

The companies also have decided to extend a single-dose Phase I study to explore higher doses. Regulatory approval has been obtained for this trial extension, Sosei said.