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news.Neurocrine Biosciences has received communication from the FDA indicating that the new drug application for indiplon 5mg and 10mg capsules for the treatment of insomnia is approvable pending additional clinical and preclinical data.
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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.”