NVDL'S 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.
Novadel's North American licensee is currently finalizing commercialization plans for this new product.
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 commercialization in regions other than North America.
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.
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.
Novadel's North American licensee is currently finalizing commercialization plans for this new product.
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 commercialization in regions other than North America.
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.
