Pfizer’s sleeping aid approval delayed by FDA

The FDA has not approved Indiplon, Pfizer’s new sleeping aid developed with Neurocrine Biosciences, as it has sent a letter to the companies demanding that certain criteria are met before it can be approved.

Neurocrine said that the FDA stated that its five milligram and ten milligram variants were approvable, but not the 15 milligram version. The company said it would converse with the FDA to attempt to gain full approval for the product, but it did not say what exactly the FDA were looking for.

Gary A. Lyons, president and chief executive officer of Neurocrine, said: “While we are disappointed in the FDA action, we will move forward expeditiously to address FDA’s outstanding questions regarding the applications.”

“We are heartened by the approvable action for indiplon capsules and are dedicated to working with the Agency to expedite response to the action letters,” he added.

Neurocrine shares fell by 60 per cent yesterday after the news was released, while Pfizer shares fell by 23 cents. Shares of rival companies that make sleeping drugs, such as Sanofi-Aventis and Sepracor, rose at the same time.

Pfizer, which would pay $109 million (57.4 million pounds) to Neurocrine on the approval of the product, did not comment on the FDA’s decision.

Pharmaceutical research company LeadDiscovery said that the world’s sleep disorder market was worth $2.03 billion in 2004, largely dominated by Sanofi-Aventis’ Ambien drug. It says that the market will more than double by 2010 and that there will be at least five key products on offer, as opposed to the one currently.

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