NovaDel Announces Extension of PDUFA Review Deadline for Insomnia Drug
NovaDel Pharma, a specialty pharmaceutical company, has announced that the FDA has requested an extension of up to three months on the Prescription Drug User Fee Act deadline in order to complete the review of the company’s Zolpimist oral spray for the short-term treatment of insomnia.
Based on the original Prescription Drug User Fee Act (PDUFA) date for Zolpimist, the FDA will reply on or before December 19, 2008. NovaDel submitted its Zolpimist application using the FDA’s 505(b)(2) process based on bioequivalence 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 tartrate administered as an oral spray versus tablets.
The pharmacokinetic profiles were assessed by the maximum drug concentration and total exposure to drug. 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.
Steven Ratoff, chairman of the board and interim CEO of NovaDel, said: “We believe we have submitted a high quality 505(b)(2) application for Zolpimist and will continue to work with the FDA throughout the remaining review process.”