NovaDel announced on January 23, 2008 that FDA accepted their 505(b)(2) filing for an oral spray ZolpiMist (TM). The reference listed drug is Ambien(R) Tablets. The press release indicated that the filing was based on ”two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) 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 two studies compared Cmax (maximum concentration observed), total exposure measured by AUCinf as well as Tmax, the time that maximum concentration was achieved (clearly important when you want the drug to induce sleep!). In addition to these pharmacokinetic parameters, the studies assessed the level of sedation. The latter can be done in a Phase 1 study because this drug is used for inducing sleep in a normal healthy population.
NovaDel appears to be developing several oral sprays of previously approved drugs. Their web site suggest their technology can be used to achieve faster absorption (not always a good thing).
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