By Randall Osborne
West Coast Editor
As promised, Neurocrine Biosciences Inc. began the first pivotal Phase III trial of NBI-34060, a non-benzodiazepine compound that acts against chronic insomnia through a specific site of the GABA-A receptor.
The 500-patient trial is a randomized, double-blind, parallel-group, multicenter study to evaluate the safety of two doses of NBI-34060 in its immediate-release form, at about 40 medical sites in the U.S. and Europe.
Two more pivotal Phase III trials with immediate-release NBI-34060, licensed by Neurocrine from DOV Pharmaceutical Inc., of Hackensack, N.J., are planned to begin shortly.
Neurocrine has deals with other firms such as GlaxoSmithKline plc, of London; Eli Lilly and Co., of Indianapolis; Wyeth-Ayerst Laboratories Inc., of Radnor, Pa.; and Taisho Pharmaceuticals Ltd., of Tokyo.
In October, three months after disclosing the GSK deal for corticotropin-releasing factor receptor antagonists, Neurocrine got its first milestone payment of $15.5 million, which brings the total received so far to $25.5 million. (See BioWorld Today, Oct. 30, 2001.)
But the insomnia drug has no partner helping with advancement. The condition it targets afflicts about half the adult population in the U.S., who report having trouble sleeping a few nights a week or more, says the National Sleep Foundation. About 29 percent of adults say they are affected by insomnia every night or almost every night.
NBI-34060 uses the same mechanism that the non-benzodiazepine therapeutics already on the market use for sleep-promoting effects.
Neurocrine focuses on neurological and endocrine diseases and disorders, with product candidates in insomnia, anxiety, depression, malignant brain tumors and peripheral cancers, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke and certain female health disorders.
Company officials did not return calls seeking comment.
Neurocrine¿s stock (NASDAQ:NBIX) closed Friday at $41.60, down 38 cents.