Novadel Pharma, Inc. announced that the Food and Drug Administration (FDA) has requested a 3 month Prescription Drug User Fee Act (PDUFA) extension to complete their review of Zolpimist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia.

NovaDel submitted an application for Zolpimist(TM), using the FDA’s 505(b)(2) process. The application was based on bioequivalence data from two randomized, open-label, dose-ranging studies comparing Zolpimist(TM) with Ambien(R) in young and elderly healthy volunteers. The studies compared comparable doses of zolpidem tartrate as an oral spray versus tablets and assessed speed of drug absorption and level of sedation. The pharmamacokinetic profiles were assessed by the Cmax (maximum drug concentration) and AUC 0-inf (area under the curve). The results demonstrated bioequivalence between Zolpimist(TM) and Ambien(R).

Source: Novadel Pharma, Inc.