FLEMINGTON, N.J.--(BUSINESS WIRE)--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®, 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.
