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12:00 AM
Mar 25, 2002
 |  BioCentury  |  Product Development

Insomnia's multiple faces

Most biotech companies submit regulatory filings for a new product that include one or two Phase III trials to demonstrate efficacy and a smattering of earlier phase trials to show dosing and safety. But Neurocrine Biosciences Inc. is running a clinical program for its NBI-34060 in insomnia that looks more like a big pharma story.

The company is committed to completing eight large Phase III trials of NBI-34060 in a program that is designed to show efficacy in patients with different forms of the disorder by splitting up patients upfront instead of running multiple subgroup analyses.

Last week, NBIX (San Diego, Calif.) began three Phase III trials of its immediate release formulation of NBI-34060 IR, adding to one ongoing Phase III trial, and the company said that this year it will start another three trials with its modified release NBI-34060 MR. A final study will assess the effects of interrupting use of the non-benzodiazepine GABA(A) agonist (see B18).

Paul Hawran,...

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