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BioTie has completed a phase II clinical study of nalmefene tablet intended for the treatment of impulse control disorders. A phase II study in patients suffering from pathological gambling demonstrated that nalmefene reduced gambling related urges and behavior statistically significantly compared to placebo.
The multi-center, placebo controlled study of 200 patients in the U.S. focused on the safety and efficacy of daily oral administration of nalmefene in patients suffering from pathological gambling. A psychometric scale (PG-YBOCS, developed by Drs. Hollander and DeCaria at Mount Sinai Hospital, New York) measuring gambling-related thoughts, urges and behavior was used for primary evaluation of efficacy.
Based on the study results nalmefene was effective in patients suffering from pathological gambling: after four months treatment, mean scores on the PG-YBOCS scale were almost twice as high in patients who were on placebo when compared to the patients receiving nalmefene. The difference between the study groups was statistically significant. No serious adverse effects related to the use of nalmefene were observed during the study. The company is now seeking a licensing partner for this drug development program.
Nalmefene
Nalmefene is a specific opioid receptor antagonist that inhibits the effects of endorphins in the central nervous system. Endorphins are believed to have a central role in the development of dependence disorders, such as alcoholism. It has been suggested that the neurobiological basis of impulse control disorders may have substantial similarity to that of addictions.
Pathological gambling
In the U.S., it is estimated that approximately 1.4-2.8 percent of the adult population suffer from pathological gambling and in Europe the number varies by country between 1-3 percent. Pathological gambling was included in the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1980, but there is no approved drug therapy available for this condition. Psycho-social therapy is currently the main treatment modality for patients suffering from pathological gambling. To the company's knowledge, the now completed study is the first industry sponsored large scale phase II clinical study in this indication. In terms of suitability for pharmacotherapy, pathological gambling has been considered a representative condition within a variety of impulse control disorders (such as kleptomania, compulsive shopping, pyromania).
Biotie Therapies Corp. in brief
BioTie's objective is to become a leading research and drug development company in the selected therapy areas by converting high impact scientific discoveries into pharmaceutical success. BioTie develops novel and patented pharmaceuticals for global markets with unmet medical need and large commercial potential. BioTie focuses on inflammatory diseases, dependence disorders and glycomics.
For further information, please contact:
Jari Saarinen, President and CEO
Biotie Therapies Corp.
tel. +358 2 274 8954, mailto:jari.saarinen@biotie.com
Timo Veromaa, M.D., Ph.D.
Vice President, Research and Development
Biotie Therapies Corp.
tel. +358 2 274 8901, mailto:timo.veromaa@biotie.com
http://www.biotie.com
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