Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

D&A PHARMA Presents 3 Major Clinical Studies at the 14th Congress of ESBRA

Published: Monday, September 09, 2013
Last Updated: Monday, September 09, 2013
Bookmark and Share
Company will present the results of several international clinical studies (essentially GATE 1,GATE 2 and GUM) including a population of 2.500 alcohol-dependent patients.

D&A PHARMA has announced its strong participation in the 14th Congress of European Company of Biomedical Search on the Alcoholism (ESBRA), which will be held in Warsaw from September 8th to 11th.

During this Congress, D&A PHARMA will present the results of several clinical studies (GATE 1, GATE 2 et GUM) for ALCOVER® (Sodium Oxybate), a breakthrough treatment of alcohol dependence.

All presented data confirm that Sodium Oxybate favorably meets the therapeutic objectives set by experts and by health authorities (EMA, FDA) for the management of alcohol-dependence.

• GATE 1 study included 127 dependent patients, confirms the efficacy of ALCOVER® in the processing of the syndrome of weaning occurring at the time of the stop of the alcoholic intoxication.

• GATE 2 study included a 6-month double-blind treatment with ALCOVER® or placebo, followed by a 6-month untreated period. ALCOVER® was statistically significantly better than placebo at 6 months and the difference was maintained at 12 months. Three hundred and fourteen alcohol-dependent patients from 4 European countries participated in GATE 2 study. On September 9th, D&A PHARMA will present in detail the outcomes of these studies in an official satellite symposium of the ESBRA as well as in a poster and oral presentations. The satellite symposium is entitled: « Sodium Oxybate: Breakthrough in the Treatment of Alcohol Withdrawal Syndrome and Maintenance of Alcohol Abstinence ».

These two multicenter studies have been conducted in Germany, Austria, Italy and Poland.

• The GUM study (GHB - Use and Misuse) is a longitudinal retrospective study that has analyzed 604 patient files. Patients had a severe alcohol dependence, and for some of them, co-addictions or psychiatric co-morbidities. The study has been performed from 2005 to 2007 in seven centers from Northern Italy.

The study demonstrated that ALCOVER is effective and safe when prescribed in the therapeutic dose interval: in the treatment of alcoholic withdrawal syndrome (detoxification), 81% of patients were successfully detoxified. In the prevention of relapses and maintenance of alcohol abstinence maintenance, 75% to 80% of patients remained abstinent 12 months after the initiation of alcohol treatment.

Dr Felice Nava, Director of Scientific Committee of the Italian Society of Addiction Medicine (FeDerSerD), commented: “All these studies have proved the efficacy and the safety of Sodium Oxybate on the current criteria of evaluation required by the European Medicines Agency. It is the case both in the treatment of the withdrawal syndrome and in the prevention of alcohol relapses and this, without any addictive effect observed”.

Patrice Debrégeas, chairman of D&A PHARMA, concluded: “We are very proud of all the aggregated clinical data for ALCOVER®. All these long-term studies show the efficacy and the great safety of use of ALCOVER®. In addition to these strong results makes it possible to the patients to avoid to benzodiazepines, strongly sedative drugs, during the detoxification period and to continue the same treatment on the long term, which is unique among anti-alcohol drugs and optimizes significant fact in the treatment of the alcoholic dependence. This is a major competitive advantage and an important benefit for all alcoholic patients. As an independent pharmaceutical company, it is a great honor to present to the largest KOLs’ panel in the field of alcohology and addictology all these major results at a moment when D&A PHARMA is filing for approval in a secured formulation of ALCOVER® several European agencies in order to market the product in the European Union in 2014, while ALCOVER® has been successfully marketed for 20 years in Italy and 14 years in Austria, allowing to treat successfully 350.000 patients who are 100% refunded at 100% by public healthcare organizations”.

In addition to its participation in the 14th Congress of ESBRA, D&A PHARMA will organize on September 7th, 2013, always at Warsaw, its International Expert Board, gathering about thirty leading specialists and fundamental scientists in alcohology and addictology.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More Than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
How a Genetic Locus Protects Adult Blood-Forming Stem Cells
Mammalian imprinted Gtl2 protects adult hematopoietic stem cells by restricting metabolic activity in the cells' mitochondria.
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
The MaxSignal Colistin ELISA Test Kit from Bioo Scientific
Kit can help prevent the antibiotic apocalypse by keeping last resort drugs out of the food supply.
"Good" Mozzie Virus Might Hold Key to Fighting Human Disease
Australian scientists have discovered a new virus carried by one of the country’s most common pest mosquitoes.
Non-Disease Proteins Kill Brain Cells
Scientists at the forefront of cutting-edge research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s have shown that the mere presence of protein aggregates may be as important as their form and identity in inducing cell death in brain tissue.
Closing the Loop on an HIV Escape Mechanism
Research team finds that protein motions regulate virus infectivity.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos