Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



Zolpidem Oral Spray As an Alternative to Ambien


Posted on 2006-10-31 08:33:00



NovaDel Pharma Inc. today announced positive results from a pilot pharmacokinetic study comparing its new and improved formulation of Zolpidem Oral Spray to Ambien tablets. Zolpidem is the active ingredient in Ambien, Sanofi-Aventis' leading treatment for insomnia.

In the study, subjects received Zolpidem Oral Spray or Ambien® tablets in 5mg or 10mg doses. For fasting subjects, fifteen minutes after dosing, 80% of subjects using Zolpidem Oral Spray achieved blood concentrations of greater than 20 ng/ml, compared to 33% of subjects in the 5mg Ambien® tablet group and 40% of subjects in the 10mg Ambien® tablet group. The difference between the oral spray groups and tablet groups was statistically significant (p=0.016). Twenty ng/ml is a level generally believed to approximate the lower limit of the therapeutic range for zolpidem. Additionally, drug concentrations were measured at five and ten minutes post-dosing. At these early time points, the oral spray groups achieved drug levels five-to-thirty times greater than subjects in the corresponding tablet groups. These differences were also statistically significant.

"The performance of Zolpidem Oral Spray in this study indicates that this formulation has the potential for faster induction of sleep when compared to Ambien® tablets," said Dr. Thomas Roth, Chief of Sleep Medicine at Henry Ford Hospital in Detroit, Michigan, the former Chair of the National Center of Sleep Disorders Research of the National Institutes of Health, Chairman of the World Health Organization (WHO) worldwide project on sleep and health. "Insomnia is a frustrating, often debilitating condition, and there is a real need for improved products to bring faster onset of sleep to these patients."

"We expect that faster achievement of therapeutic drug concentration levels will translate into more rapid onset of sleep, which is a key objective for any sleeping medication being developed," stated Jan Egberts, M.D., President and CEO of NovaDel. "This study once again demonstrates the potential of NovaDel's oral spray technology to provide considerable benefits to patients in the form of faster-acting and more convenient dosing options. Based on these results, we plan to advance Zolpidem Oral Spray into pivotal trials in the first quarter of 2007 and submit a 505(b)(2) New Drug Application with the U.S. Food & Drug Administration by the end of the second quarter of next year."


NEWS ARCHIVES

2008

2007

2006

2005

2004

NEWSLETTER SIGNUP