Navigation Links
NovaDel Announces Positive Data from Two Studies Comparing Zolpidem,Oral Spray to Ambien Tablets

post-dosing when compared to subjects using 10 mg tablets. These results are statistically significant (p less than 0.001).

-- Subjects using the 5 mg oral spray showed a more than twofold reduction of DSST scores compared to subjects using 5 mg tablets. These results are statistically significant (p less than 0.005).

-- A cross analysis between 5 mg oral spray and 10 mg tablets demonstrated that subjects using 5 mg oral spray showed more than twice the reduction in DSST scores versus subjects using 10 mg tablets. These results are also statistically significant (p less than 0.008).

ABOUT THE STUDIES

The first, single-center study (NVD003) was a randomized, 4-way crossover, open-label, dose-ranging, pharmacokinetic and pharmacodynamic study in 44 healthy volunteers (21 females, 23 males, mean age = 29.4 years). This study compared 5mg and 10mg doses of zolpidem oral spray to the same doses of Ambien(R) tablets. The second, single-center study (NVD004) was a randomized, 2-way crossover, open-label, pharmacokinetic and pharmacodynamic study in 24 elderly healthy volunteers (18 females, 6 males, mean age = 71.0 years). This study compared 5mg zolpidem oral spray to 5mg Ambien(R) tablets.

The objectives of the studies, comparing zolpidem oral spray to tablets under fasting conditions, were as follows: establish pharmacokinetic parameters (e.g.: Cmax and AUCs); measure time to reach therapeutic benefit while collecting safety and tolerability information; assess pharmacodynamic properties as measured by the sleepiness/alertness levels associated with study drug administration. Researchers administered to all participants the Digit Symbol Substitution Test (DSST), a measurement of cognitive and motor functions indicative of sleepiness and sedation. The reduction in the DSST score from pre-dosing baseline to 13 minutes post-dosing was pre-specified as a pharmacodynamic objective. In addition, researchers administered a 12-item Visual Anal
'"/>




Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
3. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
4. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
5. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
8. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
9. Protox Announces Positive Clinical Data from Prostate Cancer Study
10. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
(Date:12/24/2014)... Mexico , Dec. 24, 2014  Novastem, ... of its first patient in its study for ... the American Stroke Association, ischemic strokes account for ... to enroll qualified patients in the study, entitled ... Administration of Allogeneic Mesenchymal Stem Cells and Intrathecal ...
(Date:12/24/2014)... 24, 2014  Commonwealth Cornerstone Group (CCG) today announced the ... on Tuesday to help fund the expansion and consolidation of ... Sharon . PHN is the ... . It is the largest employer in ... people on staff. Currently, PHN Sharon offers scattered ...
(Date:12/24/2014)... N.Y. , Dec. 24, 2014 Kinex ... dosed with KX2-361 at Roswell Park Cancer Institute. ... small molecule drug that has shown potent inhibitory activity ... including those that are resistant to Temozolomide (T98G), the ... glioma. In a well-established brain tumor mouse model, KX2-361 ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3
... Calif., Nov. 10, 2011 Highlights from ... of action observed in placebo-controlled trials Comparative ... Safety and efficacy in post-prostatectomy population ... that multiple abstracts will be presented at the Sexual Medicine ...
... ALBANY, New York, November 10, 2011 According ... http://www.transparencymarketresearch.com ) " North America & Europe Minimally ...  " the prostate cancer minimally invasive surgical device ... be $14.2 billion in 2011 and expected to reach $24.9 ...
Cached Medicine Technology:Avanafil Data to be Presented at the Sexual Medicine Society of North America Meeting 2Avanafil Data to be Presented at the Sexual Medicine Society of North America Meeting 3Avanafil Data to be Presented at the Sexual Medicine Society of North America Meeting 4Avanafil Data to be Presented at the Sexual Medicine Society of North America Meeting 5Transparency Market Research: The North America and Europe Minimally Invasive Prostate Cancer Surgery Market is Booming: Expected to Attain a Market Size of USD 24.9 Billion by 2016 2Transparency Market Research: The North America and Europe Minimally Invasive Prostate Cancer Surgery Market is Booming: Expected to Attain a Market Size of USD 24.9 Billion by 2016 3Transparency Market Research: The North America and Europe Minimally Invasive Prostate Cancer Surgery Market is Booming: Expected to Attain a Market Size of USD 24.9 Billion by 2016 4Transparency Market Research: The North America and Europe Minimally Invasive Prostate Cancer Surgery Market is Booming: Expected to Attain a Market Size of USD 24.9 Billion by 2016 5
(Date:12/24/2014)... December 25, 2014 AlignLife of Wauwatosa ... to afford certain items. During the holiday season, AlignLife looks ... over 70 toys," says Dr. Sara Mahalko-Leonhardt, owner of AlignLife. ... such joy, knowing that we are able to give kids ... it not been for the generosity of our patients." , ...
(Date:12/24/2014)... 2014 Recently, iFitDress.com, a famous dress manufacturer ... dresses under $150 . All these items are brand new; ... has already been updated with the new range of high ... so far. All iFitDress.com’s designs are made according to the ... great materials. Every outfit from the company is handpicked by ...
(Date:12/24/2014)... York (PRWEB) December 24, 2014 ... ) that allege the blood thinner caused life-threatening ... outlined a leadership structure for the proceeding, Bernstein ... December 17th, the Court plans to select lawyers ... and also plans on appointing a Plaintiffs’ Steering ...
(Date:12/24/2014)... Oregon (PRWEB) December 24, 2014 ... Rehab sat down with Derek Fenwick, PT, MBA, ... changes that will stem from the passing of the ... (IMPACT Act). In this taping of the Infinicast, ... title XVIII of the Social Security Act to standardize ...
(Date:12/24/2014)... Dec. 24, 2014 (HealthDay News) -- Hepatitis C infection does ... to a new study. Treatment advances have made it ... many develop memory and thinking problems, mood swings and other ... said. It,s believed that long-term infections with other viruses ... affect the brain. One of the prime suspects has been ...
Breaking Medicine News(10 mins):Health News:AlignLife of Wauwatosa Brings Joy to Less Fortunate Families 2Health News:Many Prom Dresses under 150 from Well-known Dress Manufacturer iFitDress.com 2Health News:Court Overseeing Federal Xarelto Lawsuits Issues Coordination Order, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal Xarelto Lawsuits Issues Coordination Order, Bernstein Liebhard LLP Reports 3Health News:Latest Episode of Infinicast Features Infinity Rehab President Discussing IMPACT Act of 2014 and Changes for Post-Acute Therapy Providers in 2015 2Health News:Hepatitis C Infection Isn't Related to HIV Brain Woes: Study 2
... -- A fetus is sensitive to, and can be affected ... University of California, Irvine, researchers recruited pregnant women and ... The women,s babies were tested after birth to assess how ... state appeared to be important to a baby,s well-being. Development ...
... , THURSDAY, Nov. 17 (HealthDay News) -- ... severe mood dysregulation spend less time looking at the ... children without the psychiatric disorders, researchers say. This ... bipolar disorder and severe mood dysregulation have difficulty determining ...
... who identify themselves as such in the workplace are ... their job than transsexuals who do not, according to ... University. "Trans-parency in the Workplace: How the ... in an upcoming issue of the Journal of ...
... that has set standards for teaching women and clinicians ... around the country to detect lumps earlier and save ... of early detection of cancer. The Center for Disease ... cancer is the most common cancer among American females. ...
... 2011 InDevR, a Boulder-based biotechnology company that ... analysis of viruses and other microorganisms, announced today ... ampliPHOX, a colorimetric detection system that incorporates core ... Transfer Office, will enhance laboratories around the world ...
... 17 (HealthDay News) -- Young athletes who routinely take hits ... they do not suffer a concussion, according to the results ... of Rochester Medical Center (URMC) said their findings could be ... mild head injuries among young people whose brains are still ...
Cached Medicine News:Health News:Mom-to-Be's Mental State May Affect Child's Development 2Health News:Bipolar Kids May Focus on Different Facial Features 2Health News:'Trans-parency' in the workplace 2Health News:Indevr launches breakthrough colorimetric detection for microarrays using core technology from CU 2Health News:Routine Head Hits in Sports May Injure Brain, Experts Warn 2
... innovative & portable FireFly LED light offers ... With the new FireFly LED you'll get ... go whereever your practice demands. High center-beam ... on your procedures, while the rechargeable battery ...
... LED headlight provides superior Illumination in an ... you'll get bright center-beam light with a ... direct it all totally hands free. ... quality materials to fit any manufacturers loupe ...
Easy pull-on garment's feature Rainey's exclusive Non-Slip Dome™design and adjustable Velcro© closure at neck for optimal comfort and support. Choose covered or non covered ear design....
For face-lifts and submental liposuction...
Medicine Products: