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

FLEMINGTON, N.J.--(BUSINESS WIRE)--Jun 5, 2007 - NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, today announced that its two clinical studies comparing zolpidem oral spray with zolpidem tablets have met their primary pharmacokinetic (PK), pharmacodynamic (PD) and safety objectives. Zolpidem tablets are currently marketed as Ambien(R), a leading drug for the treatment of insomnia. Today's results confirm and expand upon results from NovaDel's earlier pilot PK and PD studies of zolpidem oral spray and support the Company's objective to submit a new drug application (NDA) this year for zolpidem oral spray using the FDA's 505(b)(2) regulatory process.

"These positive results for zolpidem oral spray further demonstrate the potential for NovaDel's technology to create meaningful improvements in the performance and ease of administration of widely used pharmaceuticals. With today's data, we believe we have completed the clinical requirements for submission of our NDA and we are on track to finalize all manufacturing, safety and regulatory work necessary to submit our NDA during 2007," commented Jan H. Egberts, M.D., NovaDel's President and CEO. "Importantly, these data also suggest that our oral spray may provide earlier therapeutic drug concentrations and a more rapid pharmacodynamic effect, even while administering lower doses of zolpidem."

Objectives of the Studies

NVD003 compared 5 mg and 10 mg doses of zolpidem oral spray with comparable doses of Ambien(R) tablets in healthy volunteers. NVD004 compared doses of 5 mg zolpidem oral spray to 5 mg Ambien(R) tablets in elderly, healthy volunteers. The primary objective of both studies was to demonstrate comparability of pharmacokinetics between oral spray and tablet groups as determined by the maximum drug concentration (Cmax) and total exposure to drug (are
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