In a single center, randomized, placebo-controlled study of 76 smokers, patients in the nalmefene 40mg group demonstrated numerically higher abstinence rates at all timepoints relative to placebo. Patients in the nalmefene 80mg group did not consistently achieve abstinence rates that were numerically superior to placebo. The study was not designed to demonstrate statistical significance.
Nalmefene was generally well tolerated, with an adverse event profile similar to that observed in studies previously conducted with the drug.
“We are encouraged by the results of our first smoking cessation clinical study which was designed to be exploratory in nature,” commented Somaxon’s chief medical officer, Dr Phil Jochelson. “We are intrigued with the observation that the nalmefene 40mg treated patients maintained higher abstinence rates relative to placebo.”
Somaxon is also currently evaluating nalmefene in the treatment of pathological gambling, with results from a large clinical trial expected early next year.