The agency determined that indiplon 5mg and 10mg capsules are 'approvable' but considered the all-important 15mg extended release version of the drug to be 'not approvable.'
The rejection of the 15mg dose of the drug is a major blow to the company. It was this dosage which was expected to drive most of the sales for the drug because it not only induces sleep but maintains it throughout the night.
Analysts, who had thought the drug could reach blockbuster status, now predict that the lower doses will generate only a fraction of the revenue as it struggles to compete with generic, and therefore cheaper, competition.
According to Neurocrine, the FDA indicated that it did not have an opportunity to review all of the information submitted on the drug during the NDA review cycles.
An 'approvable' response from the FDA usually means that the agency requires the company to submit additional data in support of its application. This can constitute a considerable delay if the additional data required necessitates further clinical studies.
“While we are disappointed in the FDA action, we will move forward expeditiously to address FDA's outstanding questions regarding the applications,” said Gary Lyons, president and CEO of Neurocrine.