SAN DIEGO, Sept. 5 (UPI) -- Neurocrine said Tuesday the U.S. Food and Drug Administration wants another study before it can approve insomnia treatment indiplon.
The FDA had previously issued an approvable letter for indiplon.
Neurocrine recently had an end-of-review meeting with the agency about indiplon and said the FDA requested a study to supplement the pharmacokinetic/food effect profile of the drug to include several meal types.
Neurocrine said it would initiate the study shortly after consultation with the agency. The company said the FDA did not require any other clinical trials.
"Subject to those further consultations with the FDA we are expecting to provide a complete re-submission sometime before the end of the second quarter 2007," said Gary Lyons, Neurocrine's president and chief executive officer.
Neurocrine said its resubmission will also include additional analyses and modifications of previous analyses to address questions raised by the agency.
The company said another meeting with the FDA to discuss and clarify action items for indiplon is scheduled for late October 2006.
