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news.NovaDel Pharma has initiated a clinical trial of its proprietary formulation of zolpidem oral spray that will be key to the company's new drug application for the insomnia drug candidate.
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Zolpidem is the active ingredient found in the number one selling hypnotic, Ambien (zolpidem tartrate), which is marketed by Sanofi-Aventis. The trial, which is being conducted in healthy human volunteers, is designed to evaluate the pharmacokinetic profile of NovaDel’s oral spray versus the 10mg Ambien tablet.
This trial will be a key component in NovaDel’s new drug application (NDA) filing for the spray, which is targeted for submission to the FDA in the first half of 2007.
In a previous pilot pharmacokinetic study, higher plasma drug concentration levels were observed for the oral spray at the early time points after administration. Thus, NovaDel believes, zolpidem oral spray may have the potential to shorten Ambien’s average time to onset of therapeutic action.
“NovaDel has commenced this bioequivalence trial with an optimized version of our oral spray formulation of zolpidem based on the positive results of our pilot pharmacokinetic trial,” Jan Egberts, president and CEO of NovaDel, noted.
“Zolpidem oral spray could ultimately 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 even further delayed,” he continued.