The FDA has accepted Flemington, NJ-based NovaDel Pharma’s (NVD) New Drug Application for ZolpiMist. ZolpiMist is an 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.
Following NovaDel’s regulatory strategy, the company submitted the NDA using the 505(b) (2) path. This allows a NovaDel to rely upon the FDA’s findings of safety and efficacy for a previously approved drug, shortening the development time.
NovaDel’s NDA is 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 speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist and Ambien.
NovaDel’s Spray formulations contain the drug in solution, ready to be absorbed through the oral mucosa directly into systemic circulation.
When oral spray is utilized the drug can potentially reach effective blood levels in as little as 10-15 minutes. In bypassing the GI tract and liver, the same therapeutic benefits can be achieved more quickly. The spray formulation should provide faster relief of sleeplessness; it may also be possible to achieve the same effect with a lower dose and improve the side effect profile.
In a nod to the Hana Biosciences’ partnership gone wrong, NovaDel noted that the ZolpiMist submission included data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
Back in February 2007, the FDA voiced concerns over Hana’s manufacturing of Zensana, when a precipitate was found in the scale-up batches. The development sent NovaDel shares tumbling. Hana not only had to fix the problem but repeat the FDA clearance process; that process is ongoing.