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Neurocrine’s Bad Dream Continues: Indiplon Approval Requires 3 More Trials

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

An FDA "approvable" letter for Neurocrine Biosciences' beleaguered insomnia agent indiplon requests an additional safety study comparing the 10 mg dose to a marketed product, the firm reported Dec. 13. The firm was "very surprised" by the letter, which requests three new studies in all, Neurocrine CEO Gary Lyons stated during a same-day conference call

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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