Zolpimist is NovaDel’s second product approved by the FDA that uses the company’s proprietary NovaMist oral spray technology. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien, a sedative hypnotic for the treatment of insomnia.
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 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, the company said.
Steven Ratoff, chairman of the board and interim CEO of NovaDel, said: We believe the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa.
This achievement is another major milestone for NovaDel as it further validates our ability to develop innovative drugs based on the NovaMist technology. We are actively seeking a partner to commercialize this innovative product and believe that this approval should enhance those efforts.