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Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose
Date:6/11/2008

ibed for adults at 10 mg and 12.5 mg doses respectively. These amounts are between three and four times the highest Intermezzo(R) dose available.

It is estimated that over 15 billion doses of zolpidem have been prescribed since its original approval by the FDA. Zolpidem has been shown to be safe and effective for the treatment of insomnia, but the high dose products available in the U.S. and elsewhere have been designed to produce 6 to 8 hours of sleep, and are thus unsuitable for "as needed" treatment of patients who awaken in the middle of the night and have fewer hours remaining before waking up in the morning.

About Intermezzo(R)

Intermezzo(R) (zolpidem tartrate sublingual lozenge) employs Transcept Pharmaceuticals' proprietary Bimucoral(R) technology in a mint-flavored, sublingual lozenge formulated to dissolve under the tongue in approximately two minutes. This novel approach has been shown to accelerate the bioavailability of zolpidem, despite the substantially lower Intermezzo(R) dose vs. the doses employed with previously available forms of the drug.

About Transcept Pharmaceuticals

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs. Transcept development projects leverage new understanding of CNS conditions to provide additional uses and enhanced clinical benefits for existing active agents. The lead Transcept product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge), is a low dose formulation of zolpidem for the treatment of insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep. Phase 3 clinical trials have been completed for Intermezzo(R) and Transcept plans to submit an NDA in the third quarter of 2008. Transcept is also developing TO-2060, a novel, fixed-dose combination of olanzapine and ondansetron for the treatment of dopamine associated psychiatric disorders. For further infor
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SOURCE Transcept Pharmaceuticals, Inc.
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