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Transcept Pharmaceuticals Reports Second Quarter 2009 Financial Results
Date:8/14/2009

let) has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo(R) is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo(R) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. Transcept believes that Intermezzo(R), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.

Two Phase 3 clinical studies evaluated 376 patients receiving either Intermezzo(R) or placebo. In the first study, a sleep laboratory trial using an objective polysomnographic endpoint, Intermezzo(R) demonstrated a statistically significant decrease versus placebo in the time it took patients to return to sleep as measured by Latency to Persistent Sleep. In the second study, an outpatient trial, Intermezzo(R) demonstrated a statistically significant decrease in Latency to Sleep Onset, a subjective patient reported endpoint. The most common adverse event seen in these trials was headache (2.7 percent active versus 1.4 percent placebo in the outpatient study).

The FDA has established October 30, 2009 as its target date under PDUFA to take action on its review of the NDA. Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).

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Transcept Pharmaceuticals, Inc.
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Related medicine news :

1. Transcept Pharmaceuticals to Report Second Quarter 2009 Results
2. Transcept Pharmaceuticals to Hold Conference Call on Agreement with Purdue Pharmaceutical Products L.P. to Commercialize Intermezzo(R) in the United States
3. Transcept Pharmaceuticals to Present at BMO Capital Markets Healthcare Conference on August 5, 2009
4. Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo(R)
5. Transcept Pharmaceuticals to Present at Needham Life Sciences Conference on June 10, 2009
6. Transcept Pharmaceuticals Presents Data from Studies of Two Product Candidates at Annual Meeting of the American Psychiatric Association
7. Transcept Pharmaceuticals Reports First Quarter 2009 Financial Results
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9. Transcept Pharmaceuticals Reports Fourth Quarter and Year End 2008 Financial Results
10. Transcept Pharmaceuticals to Report Fourth Quarter 2008 Results
11. Transcept Pharmaceuticals to Present at Two Upcoming Conferences
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