D&A Pharma: a Retrospective Study on the Use of ALCOVER® in Italy Confirms the Efficacy of the Drug With 81% of Patients Successfully Detoxified
Published: Jul 11, 2012
This study which acronym is GUM (GHB Use and Misuse) is a longitudinal retrospective study which included 604 patient’s files with ALCOVER® prescription during the years 2005, 2006, and 2007. Ten alcohology centres from Northern Italy participated to the study. ALCOVER® has been marketed in Italy for more than 15 years.
The study included alcohol-dependent patients treated by ALCOVER® in the context of usual diagnostic and therapeutic procedures of each centre. The study has confirmed the efficacy of ALCOVER® in the treatment of alcohol withdrawal syndrome with 81% of patients successfully detoxified.
ALCOVER® has also proved effective for the maintenance of alcohol abstinence, with more than 75% of patients completely abstinent, 6 and 12 months after initiation of treatment.
The study has also demonstrated that the drug is safe and easy to use in the therapeutic interval (50-100 mg/kg/day). It is remarkable that very few cases of drug misuse were observed, and virtually no misuse was observed in patients without co-addiction. Moreover, 82% of patients with treatment duration inferior to 90 days were treated as outpatients while those treated during 6 to 12 months were all treated as outpatients.
In the less than 90 days group, only 19% of patients experienced mild and transient side effects (dizziness, nausea, and less commonly vomiting). In the 6- to 12-month group, no side effects were observed.
The study coordinator was Pr Felice NAVA, Director of Scientific Committee of the Italian Society of Addiction Medicine (FeDerSerD) and renowned addictologist. This study has confirmed the efficacy and safety of ALCOVER® in severe alcoholic patients treated in alcohology centers in Italy. The complete results of GUM study will be soon published in a peer-reviewed international medical journal and presented in international specialized congresses of alcohology/addictology.
M. Patrice DEBREGEAS, chairman of D&A PHARMA, has declared: “As specialists of the therapies of substance addiction, these extremely positive results reinforce the adequacy of our strategy of development. The study has also shown that 18% of treated patients also had evidence of C viral hepatitis (CVH), due to a high prevalence of CVH in relation with intravenous viral contamination associated with co-addictions. In these patients, the incidence of CVH was correlated with the presence and severity of the associated hepatic alcoholic disease.”
About D&A Pharma
D&A Pharma is a pharmaceutical company dedicated to the development and the supply of innovative treatments in the fields of various addictions such as alcohol, heroin and cocaine.
The Company intends to quickly develop its activities worldwide with ALCOVER®, a treatment of the alcoholic dependence already prescribed and marketed in Italy and Austria, for which it has acquired the exclusive license. Two other molecules for heroin and cocaine addictions are also under development at clinical and pre-clinical stages. Founded in 2006 by Sabine Cheyrou and Patrice Debrégeas, cofounder of the Ethypharm Laboratories, D&A Pharma headquarters is located downtown Paris (8th District) and the R&D and production site is based in Houdan, 60 Km to the west of Paris.
The company employs 50 people.
For more information please visit: http://www.da-pharma.fr/
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