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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
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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.

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