PRODUCT NEWS: FDA Accepts for Filing New Drug Application for Oral Spray to Treat Insomnia

FDA Accepts for Filing New Drug Application for Oral Spray to Treat Insomnia NovaDel Pharma, a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, announced that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for ZolpiMist™ (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.

NovaDel submitted its ZolpiMist application using the FDA’s 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist with Ambien® tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies.

The results demonstrated bioequivalence between ZolpiMist and Ambien. Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.

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