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Oral Spray Approved for Short-term Treatment of Insomnia
“We believe the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” commented Steven B. Ratoff, Chairman of the Board and Interim CEO of NovaDel. “This achievement is another major milestone for NovaDel as it further validates our ability to develop innovative drugs based on the NovaMist technology. We are actively seeking a partner to commercialize this innovative product and believe that this approval should enhance those efforts.”
NovaDel submitted its Zolpimist application using the FDA’s 505(b)(2) process based on data from two randomized, open-label, dose-ranging studies comparing Zolpimist with Ambien tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The pharmacokinetic profiles were assessed by the maximum drug concentration (Cmax) and total exposure to drug (area-under-the-curve/AUC0-inf). The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between Zolpimist and Ambien. Also included in the submission were data from process validation and registration stability batches produced at the intended commercial manufacturing facility.
Important Safety Information
Zolpimist is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Due to its rapid onset of action, patients should take Zolpimist immediately before bedtime and be prepared to get a full night’s sleep (7-8 hours). Patients should use extreme care in or avoid engaging in activities requiring full alertness such as driving or operating hazardous machinery the morning after taking any sleep medication. Do not take any sleep medicine with alcohol. Complex behaviors such as somnambulism (sleepwalking), including driving or eating while not fully awake, with amnesia for the event, as well as cases of severe allergic reactions have been reported in patients who have taken a sedative hypnotic. Patients reporting such events should contact their physician immediately, discontinue use and not be rechallenged. Prolonged usage of a sedative hypnotic should be avoided without first consulting a physician. Patients experiencing unusual changes in thinking or behavior, or if sleep problems persist, should see their physician as these may be indicative of another medical condition. Sedative hypnotics are non-narcotic, however they do have some risk of dependency. The most commonly observed side effects in controlled clinical trials were headache, somnolence and dizziness. For full prescribing information, including the FDA medication guide and patient instructions for use, please visit www.novadel.com.
Ambien is a registered trademark of sanofi-aventis. Zolpimist is a pending trademark of NovaDel Pharma Inc. NovaMist is a pending trademark of NovaDel Pharma Inc.
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. 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 2006 was approximately $3.4 billion, growing to $3.8 billion by 2011. Ambien/Ambien CR™ (zolpidem tartrate) and generic zolpidem tartrate are the dominant prescription drugs totaling more than 70% of the market in 2006. The patent on Ambien has expired and generic products were introduced.
Source: NovaDel Pharma