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NovaDel Announces Positive Data from Two Studies Comparing Zolpidem,Oral Spray to Ambien Tablets

In this analysis, time to reach therapeutic drug concentration levels of 20 ng/ml was measured for healthy volunteers in the NVD003 study. This analysis yielded the following results:

-- 79% of subjects using the 10 mg zolpidem oral spray reached therapeutic levels at 15 minutes post-dosing while only 26% of subjects using 10 mg tablets reached therapeutic levels at that time point. The difference between these two rates is statistically significant (p less than 0.0001).

-- 65% of subjects using the 5 mg zolpidem oral spray reached therapeutic levels at 15 minutes post-dosing while only 19% of subjects in the tablet group reached therapeutic levels by 15 minutes. This result is statistically significant (p less than 0.0003) in favor of the oral spray group.

-- A cross analysis between 5 mg oral spray and 10 mg Ambien(R) tablets showed that subjects using 5 mg oral spray reached therapeutic levels significantly faster at 15 minutes post-dosing than those using 10 mg tablets. These results are statistically significant (p less than 0.0002).

Overall analysis of the number of subjects reaching therapeutic levels by 15 minutes post-dosing suggests the potential of faster induction of sleep at lower drug doses may be achieved by using oral sprays.

Additional PD Assessment: Change in DSST to Measure Sedation

Patients in both zolpidem oral spray studies performed the digital symbol substitution test (DSST). According to Dr. Tom Roth, Director of Sleep Medicine at Henry Ford Hospital in Detroit, "DSST measurements are a scientifically, well accepted surrogate for sedation and a significant reduction in DSST score may indicate earlier onset of therapeutic action for these drugs."

NovaDel's findings from its pharmacodynamic study using DSST yielded the following results for healthy volunteers in the NVD003 study:

-- Subjects using the 10 mg oral spray showed a nearly fourfold greater reduction of DSST score at 13 minutes
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