Federal health officials held off Tuesday approving a new sleeping pill, telling Neurocrine Biosciences Inc. they need more time to review its application, the San Diego company said.
The Food and Drug Administration said it could not yet approve a 15 milligram, extended-release tablet version of the drug known formally as indiplon, Neurocrine Biosciences said. The FDA said 5 milligram and 10 milligram capsules of indiplon are “approvable.” That interim announcement generally means the agency requires a company to submit more information or meet other criteria before it can grant a product final approval, FDA spokeswoman Kimberly Rawlings said.
However, analyst Jason Napodano said it was the 15 milligram tablet that was slated to bring in the bulk of the product’s revenue because it is formulated to help people fall asleep as well as keep them sleeping. The lower dose capsules can just help people fall asleep, putting them on the same plane as the short-acting version of Ambien, expected to become generic either later this year or next.
Napodano, an analyst for Zacks Independent Research, said consumers would be unwilling to pay a premium for indiplon tablets when they don’t have an advantage over generic Ambien. Ambien is also sold in a longer-lasting controlled-release version.
Rawlings declined to say what the FDA required of Neurocrine Biosciences. In a statement, the company said that the FDA did not have enough time to review all of the information submitted in the application.
The company said it planned to discuss its application with the FDA to determine what would be needed to gain full approval for the two lower-dose capsule versions.
If approved, the drug would join an increasingly crowded and competitive market for prescription insomnia drugs. The largest players include Ambien, made by France’s Sanofi-Aventis SA, and Lunesta, a prescription medication that Marlborough, Mass.-based Sepracor Inc. launched in April 2005.