Zolpimist™
Zolpimist™ (zolpidem oral spray) uses NovaDel’s proprietary formulation technology to deliver zolpidem tartrate, which is currently marketed as Ambien®, the leading hypnotic for the treatment of insomnia. NovaDel has announced positive results from its clinical studies comparing zolpidem oral spray with Ambien® tablets. Zolpimist™
has been approved by the FDA for the short-term treatment of insomnia
characterized by difficulties with sleep initiation.
Zolpimist™ offers the potential benefit of a faster rise in drug blood levels potentially leading to a faster onset of action, without having to take water.
Clinical Studies
The Company has completed three clinical studies comparing
Zolpimist™ to Ambien® tablets. The two pivotal studies are described below:
NVD003 – Healthy volunteers with mean age of 29 years
Study NVD003 compared 5 mg and 10 mg doses of
Zolpimist™ with comparable doses of Ambien® tablets. Pursuant to FDA guidance in this type of 4-way crossover study, all data were compared to the highest marketed dose, which in this study was the 10 mg Ambien® tablet. Positive results from the study demonstrated that NovaDel’s 10 mg and 5 mg
Zolpimist™ achieved bioequivalence with 10 mg Ambien® tablets, the primary standard of reference for this study.
A secondary assessment of the relationship between speed of drug absorption and the attainment of therapeutic drug levels showed 79% of subjects using the 10 mg
Zolpimist™ reached therapeutic levels at 15 minutes post-dosing while only 26% of subjects using 10 mg tablets reached therapeutic levels at that time point. The results were statistically significant.
NVD004 – Healthy, elderly volunteers with mean age of 71 years
Study NVD004 compared doses of 5 mg
Zolpimist™ to 5 mg Ambien® tablets. The primary objective of the study was to demonstrate comparability/bioequivalence of pharmacokinetics between oral spray and tablet groups.
A secondary assessment of the relationship between speed of drug absorption and the attainment of therapeutic drug levels showed 65% of subjects using the 5 mg
Zolpimist™ reaching therapeutic levels at 15 minutes post-dosing while only 19% of subjects in the tablet group reached therapeutic levels by 15 minutes. The results were statistically significant.
Current Status
Zolpimist™ has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. NovaDel is seeking a partner for its commercialization.
Zolpimist™ for Middle-of-the-Night Awakenings (MOTN)
Clinical studies have demonstrated that a low dose of zolpidem is effective in treating a sub-set of insomnia patients who wake up during the night and have difficulty falling back asleep. NovaDel has begun development of a lower dose version of Zolpimist™ with the intent of performing clinical trials to demonstrate the benefit of an easy-to-use oral spray form of zolpidem in this important and large patient population.
About Insomnia
Insomnia is a sleep disorder whose sufferers experience inadequate or poor quality sleep and report one or more of the following: difficulty initiating sleep, difficulty maintaining sleep, and waking up too early. According to the “2005 Sleep in America Poll,” 54% of those surveyed indicated they experience at least one symptom of insomnia a few nights per week. Approximately one third of insomniac suffer from middle-of-the-night awakenings. Only approximately 14% of the respondents reported using any sort of sleep-aid therapy. Walsh and Engelhardt (1999) estimated $14 billion is spent each year on the direct costs of insomnia, including pharmaceuticals, healthcare services and hospital and nursing home care. Cowen & Company estimated the total non-benzodiazepine prescription market in the U.S. for the treatment of insomnia in 2007 was approximately $3.4 billion, growing to $3.8 billion by 2011. Ambien®/Ambien CR™ (zolpidem tartrate) are the dominant products with approximately 80% of the market in 2006. The patent on Ambien® has expired and generic products were recently introduced.