The earlier setbacks prompted Pfizer to scuttle its collaboration, which in turn forced Neurocrine to shrink its staff. But the company pushed ahead, meeting with agency officials last August to review their requirements. Now, the FDA wants additional clinical trial and preclinical study data. The requirements include an objective/subjective clinical trial in the elderly, a safety study, and preclinical study data evaluating indiplon during the third trimester of pregnancy, the company said.
"While we are disappointed in the FDA action, we will accept the FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required," Neurocrine's ceo, Gary Lyons, says in a statement.