NovaDel anxiety spray could rival Pfizer’s Xanax tablet

The study was designed to evaluate the pharmacokinetic (PK) profiles of various doses of NovaDel’s lingual spray compared to a 0.5mg alprazolam tablet (Xanax). NovaDel achieved its goal of delivering alprazolam via lingual spray to rapidly achieve blood levels in the same therapeutic range delivered by the currently marketed oral tablet.

With a 1mg dose, the lingual spray demonstrated a faster rate of absorption as evidenced by the mean time to achieve therapeutic drug levels – 15 minutes versus 35 minutes for the 0.5mg tablet – and by the higher percentage of maximum serum concentration (Cmax) achieved at earlier time points.

Since the study was conducted with healthy volunteers rather than in patients with anxiety, it was not designed to evaluate the anxiolytic properties of the drug. Nonetheless, certain pharmacodynamic effects of the treatments were assessable at 30 and 60 minutes post-dosing.

Based on two self-rating instruments designed to measure anxiety/tension and sleepiness/drowsiness levels, all lingual spray groups achieved numerically greater scores than the tablet on both relaxation and drowsiness parameters in 30 minutes. Despite the small sample size, some of the detected differences reached statistical significance.

Differences in pharmacodynamic effects were still statistically significant at 60 minutes post-dosing. For example, 56% and 89% of the subjects using the 0.75mg and 1mg lingual sprays, respectively, reported feeling “much more sleepy/drowsy,” compared to 0% following the oral tablet.

NovaDel is now planning to request a meeting with FDA to discuss the development program and registration requirements for this product going forward, along with a more general discussion of the entire category of benzodiazepines. Following the completion of formulation optimization efforts, NovaDel expects to move the product into full clinical development.