The 2007 approvable letter asked the company to conduct – An objective or subjective clinical trial in the elderly; a safety study assessing the rates of adverse events occurring with indiplon when compared to a marketed product and a preclinical study to evaluate indiplon administration during the third trimester of pregnancy.
Gary Lyons, president and CEO of Neurocrine, 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.”