NovaDel tests zolpidem oral spray as fast-acting sleep aid

By Elaine Rigoli

Tampa, Fla., Aug. 8 - NovaDel Pharma, Inc. said it started a clinical trial for its proprietary formulation of zolpidem oral spray.

The company said a spray version of zolpidem, the active ingredient found in the hypnotic Ambien, could benefit individuals who wish to achieve rapid onset of sleep and for patients who have just ingested a meal where absorption from a tablet would be delayed.

Thus, zolpidem oral spray may have the potential to shorten Ambien's average time to onset of therapeutic action, the company noted.

The trial, which is being conducted in healthy human volunteers, is designed to evaluate the pharmacokinetic profile of NovaDel's oral spray versus the 10 mg Ambien tablet.

This trial will be a key component in the company's New Drug Application, which is targeted for submission in the first half of 2007.

NovaDel is an emerging specialty pharmaceutical company based in Flemington, N.J.

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