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Transcept wins US approval for new insomnia drug Intermezzo

FDA finally clears the drug after two earlier knockbacks

The FDA has finally cleared Transcept Pharmaceuticals' insomnia drug Intermezzo, designed to tackle middle-of-the-night waking and difficulty in going back to sleep, after two earlier knockbacks.

Intermezzo is a new formulation of the long-established insomnia drug zolpidem tartrate that is indicated for people who go to sleep normally but wake in the night, something the company claims affects about 22 million people in the US.

It takes the form of a rapid-release tablet that is placed under the tongue and dissolves quickly to release a low dose of the drug.

The FDA cleared Intermezzo only for use in cases where there are at least four hours of bedtime remaining before a person's planned waking time.

"For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said the FDA's Robert Temple.

The agency rejected the company's application to market Intermezzo in July on concerns that taking a dose of the drug might impact a subject's ability to drive safely the following day. It had originally turned down the application in 2009, and the second rejection forced Transcept to cut 45 per cent of its workforce in order to reduce its operating costs.

The potential 'hangover' effect for Intermezzo guided the development of the low-dose versions of the drug, which is set at a maximum of 3.5mg for men and 1.75mg for women, who metabolise the drug more slowly. For comparison, older zolpidem formulations used at bedtime have dose ranges of 5mg to 12.5mg.

There is no limit on the duration on Intermezzo therapy on the label, which is a unique feature among insomnia drug. The FDA is discussing with Transcept a post-approval commitment to carry out a small study to examine the potential for mis-dosing of the drug. The packaging of the drug is colour-coded to help differentiate the gender-specific doses.

Intermezzo is Transcept's first approved product, and the company says it plans to introduce the product to the market in 2012. The launch timing depends however on discussions with Purdue Pharm, its marketing partner for the new product. Purdue is due to make a decision by December 8.

Glenn Oclassen, Transcept's president and CEO, said on a conference call that the NDA for Intermezzo would be signed over to Purdue if and when the drugmaker decides to opt in.

Transcept is also developing a low-dose form of ondansetron called TO-2061 in phase II studies as an adjunctive therapy in patients with obsessive compulsive disorder (OCD) who have not adequately responded to approved first-line therapy.

24th November 2011

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