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news.Somaxon has said that its drug nalmefene used to treat pathological gamblers has failed a phase II/II clinical.
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Nalmefene did not demonstrate a statistically significant difference compared to placebo on the primary endpoint, a test of obsessive compulsive behavior, at the doses 20 mg and 40 mg. In addition, neither dose achieved statistical significance on the secondary endpoints in the trial. The most frequently reported adverse events were insomnia, nausea and dizziness. Elevation in liver enzymes was observed in some nalmefene-treated patients.
Somaxon said it intends to assess the previously-reported results from its phase II clinical trial evaluating nalmefene for smoking cessation before making determinations regarding the future of the nalmefene program.
“The results of this clinical trial for nalmefene are disappointing. We will now perform a careful analysis of all of our nalmefene data and our assumptions underlying that program to determine what the next steps should be,” said Ken Cohen, Somaxon’s president and CEO.