NovaDel Announces Positive Results from Pilot Study of Zolpidem Oral Spray vs. Ambien(R) Tablets.
-Company Plans to Launch Pivotal Trial in First Quarter 2007-
FLEMINGTON, N.J. -- NovaDel Pharma Inc. (AMEX AMEX
See: American Stock Exchange : NVD See National Vulnerability Database. ) today announced positive results from a pilot pharmacokinetic study comparing its new and improved formulation of Zolpidem zolpidem /zol·pi·dem/ (zol-pi´dem) a non-benzodiazepine sedative-hypnotic; used as the tartrate salt in the short term treatment of insomnia. Oral Spray to Ambien([R]) tablets. Zolpidem is the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in Ambien([R]), Sanofi-Aventis' leading treatment for insomnia.
In the study, subjects received Zolpidem Oral Spray or Ambien([R]) 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([R]) tablet group and 40% of subjects in the 10mg Ambien([R]) 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([R]) tablets," said Dr. Thomas Roth, Chief of Sleep Medicine at Henry Ford Hospital Henry Ford Hospital is a hospital located in Detroit, Michigan a few blocks from Wayne State University and the New Center area, near the Fisher Building and Cadillac Place. The hospital was founded in 1915 by Henry Ford as a philanthropic project. in Detroit, Michigan “Detroit” redirects here. For other uses, see Detroit (disambiguation).
Detroit (IPA: [dɪˈtʰɹɔɪt]) (French: Détroit, meaning strait , the former Chair of the National Center of Sleep Disorders Sleep Disorders Definition
Sleep disorders are a group of syndromes characterized by disturbance in the patient's amount of sleep, quality or timing of sleep, or in behaviors or physiological conditions associated with sleep. 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 de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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."
Study Design and Results
Zolpidem Oral Spray was evaluated in a pharmacokinetic/pharmacodynamic study. This was a crossover study comparing 10mg oral spray, 10mg tablet, 5mg oral spray, and 5mg tablet doses under fasting conditions. The 10mg oral spray group was also evaluated under fed conditions. Ten healthy male volunteers completed the study. The study's endpoints included maximum concentration of drug (Cmax); time to the maximum concentration (Tmax); Area-under-the-Curve (AUC AUC
area under curve ); and other pharmacokinetic parameters.
The pharmacokinetic evaluations also included parameters of early drug absorption. Under fasting conditions, the oral spray groups demonstrated consistently faster drug absorption than the tablet groups, while Cmax and relative bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.
n. achieved in the oral spray groups were comparable to those in the tablet groups. Zolpidem Oral Spray was well tolerated.
Researchers administered the Digit Symbol Substitution Test (DSST DSST Denver School of Science and Technology (Colorado charter school)
DSST DANTES Subject Standardized Test
DSST Direct Signal Support Team
DSST Dunlop Self Supporting Technology ) to all participants. The DSST is a complex test, and a reduction in DSST score is seen as an indicator of sleepiness and sedation Sedation Definition
Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm.
The process of sedation has two primary intentions. . For fasting subjects, results showed that as early as 13 minutes post-dosing, the 5mg and 10mg oral spray groups achieved statistically significant treatment differences in reduction in DSST scores when compared to the 10mg tablet group (p=0.009 and p=0.003, respectively). At 8 hours post-dosing, DSST scores for oral spray and tablet groups were comparable, suggesting similar next-day residual effect in the oral spray group and the tablet group.
According to the National Institutes of Health, more than 70 million Americans experience insomnia. An estimated $14 billion is spent each year on the direct costs of insomnia, which include treatment, healthcare services and hospital and nursing home care. Indirect costs, including lost work days, property damage from accidents, and transportation to and from healthcare providers, is estimated at $28 billion annually. Insomnia 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. The insomnia market is approximately $3 billion, with Ambien([R]) leading the market. Analysts predict that the insomnia market will reach $4 billion by the year 2010.
Ambien([R]) is a registeredtrademark of Sanofi-Aventis.
About NovaDel Pharma Inc.
NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the development of novel drug delivery systems for prescription and over-the-counter drugs. The Company's proprietary oral spray technology delivery system offers the patient the potential for (i) more rapid delivery of drugs to the bloodstream allowing for quicker onset of therapeutic effects compared to conventional oral dosage forms; (ii) increased bioavailability of a drug by avoiding metabolism by the liver; (iii) improved drug safety profile by reducing the required dosage, including possible reduction of side effects Side effects
Effects of a proposed project on other parts of the firm. ; (iv) improved dosage reliability; (v) allowing medication to be taken without water; (vi) avoiding the need to swallow as is the case with many medications; and (vii) improved patient convenience and compliance. The Company plans to develop such products independently and through collaborative arrangements with major pharmaceutical and biotech companies. To find out more about NovaDel Pharma Inc. (AMEX: NVD), visit our website at www.novadel.com.
Except for historical information contained herein, this document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the successful completion of its pilot pharmacokinetic feasibility studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. and other regulatory approvals for products under development and the acceptance in the marketplace for lingual lingual /lin·gual/ (ling´gwal)
1. pertaining to or near the tongue.
2. in dental anatomy, facing the tongue or oral cavity.
1. spray products. The filing of an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. Further, the Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's most recent Annual Report and Registration Statements, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings.