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

post-dosing when compared to subjects using 10 mg tablets. These results are statistically significant (p less than 0.001).

-- Subjects using the 5 mg oral spray showed a more than twofold reduction of DSST scores compared to subjects using 5 mg tablets. These results are statistically significant (p less than 0.005).

-- A cross analysis between 5 mg oral spray and 10 mg tablets demonstrated that subjects using 5 mg oral spray showed more than twice the reduction in DSST scores versus subjects using 10 mg tablets. These results are also statistically significant (p less than 0.008).

ABOUT THE STUDIES

The first, single-center study (NVD003) was a randomized, 4-way crossover, open-label, dose-ranging, pharmacokinetic and pharmacodynamic study in 44 healthy volunteers (21 females, 23 males, mean age = 29.4 years). This study compared 5mg and 10mg doses of zolpidem oral spray to the same doses of Ambien(R) tablets. The second, single-center study (NVD004) was a randomized, 2-way crossover, open-label, pharmacokinetic and pharmacodynamic study in 24 elderly healthy volunteers (18 females, 6 males, mean age = 71.0 years). This study compared 5mg zolpidem oral spray to 5mg Ambien(R) tablets.

The objectives of the studies, comparing zolpidem oral spray to tablets under fasting conditions, were as follows: establish pharmacokinetic parameters (e.g.: Cmax and AUCs); measure time to reach therapeutic benefit while collecting safety and tolerability information; assess pharmacodynamic properties as measured by the sleepiness/alertness levels associated with study drug administration. Researchers administered to all participants the Digit Symbol Substitution Test (DSST), a measurement of cognitive and motor functions indicative of sleepiness and sedation. The reduction in the DSST score from pre-dosing baseline to 13 minutes post-dosing was pre-specified as a pharmacodynamic objective. In addition, researchers administered a 12-item Visual Anal
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