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

a-under-the-curve/AUC(0-inf)). These results will be used to support NovaDel's NDA submission this year. In addition, NovaDel also conducted assessments on the speed of drug absorption to attain therapeutic drug levels and an assessment of sedation. These results will not be used by NovaDel for its NDA submission.

Results of the Studies & Data to Support NDA Submission

NVD003 Study - Healthy volunteers

Pursuant to FDA guidance in this type of crossover study, all data were compared to the highest marketed dose, which in this study was the 10 mg Ambien(R) tablet. This dose therefore served as the primary standard of reference in this analysis. Confidence intervals (CI) for Cmax and AUC were required to be greater than 0.8 and less than 1.25 in order for zolpidem oral spray to achieve comparability against the 10 mg Ambien(R) tablet, the primary standard.

-- The NVD003 study provided definitive results in favor of 10 mg zolpidem oral spray based on the parameters of Cmax (CI = 0.839 - 1.070) and AUC(0-inf) (CI: 0.846 - 1.072). NovaDel's 10 mg and 5 mg oral sprays achieved bioequivalence with 10 mg Ambien(R) tablets, the primary standard of reference for this study. The 5 mg oral spray narrowly missed bioequivalence with the 5 mg Ambien(R) tablet achieving AUC(0-inf) (CI: 0.794 - 1.006). Further analysis revealed that 5 mg Ambien(R) tablets (when dose normalized) were not bioequivalent to 10 mg Ambien(R) tablets. These results suggest that two 5 mg Ambien(R) tablets could yield a higher plasma level than a single 10 mg Ambien(R) tablet.

NVD004 Study - Elderly, healthy volunteers

-- The NVD004 study provided definitive results in favor of 5 mg zolpidem oral spray based on the parameters of Cmax (CI: 0.922 - 1.157) and AUC(0-inf) (CI: 0.968 - 1.189). These results demonstrate that NovaDel's 5 mg oral spray was bioequivalent to the 5 mg Ambien(R) tablet.

Additional PK Assessment: Time to Reach Therapeutic Levels


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