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Pfizer's insomnia treatment hit by ruling

Published on 24/05/06 at 03:07pm

A new insomnia treatment developed by Pfizer and Neurocrine Biosciences has suffered a setback after US regulators said a high-dose version was not approvable.

Indiplon was judged approvable in its 5mg and 10mg doses, but the 15mg extended release tablets were deemed not approvable.

Even though the 5mg and 10mg capsules have been given a preliminary approval, the FDA has also requested extra information on these doses, which could cause a delay to their launch.

The drug has been forecast to earn peak sales of $850 million for the marketing partners.

Meanwhile, Takeda is due to launch a rival treatment, Rozerem, in July with a multi-million dollar direct-to-consumer campaign.

Rozerem was first approved a year ago and in the intervening period, Takeda's sales force has been promoting it as a safer, non-habit forming alternative to Sanofi-Aventis' Ambien and Sepracor's Lunesta, the biggest sellers in the category.

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