Somaxon's opiate antagonist positively affects smoking cessation in phase 2 clinical trial

By Lisa Kerner

Charlotte, N.C., July 26 - Somaxon Pharmaceuticals, Inc. said that oral nalmefene hydrochloride, an opiate antagonist, demonstrated positive results in a pilot phase 2 clinical trial for smoking cessation.

In the single center, randomized, placebo-controlled study, 76 smokers in the nalmefene 40 mg group had numerically higher abstinence rates at all timepoints, compared to a placebo.

Patients in the nalmefene 80 mg group did not consistently achieve abstinence rates superior to a placebo.

The company said the study was not powered to demonstrate statistical significance.

Nalmefene was generally well-tolerated with insomnia and nausea the most commonly reported adverse events.

Somaxon is also studying nalmefene in a large clinical trial for the treatment of pathological gambling.

The intravenous form of nalmefene is approved in the United States for the reversal of opioid drug effects.

Somaxon is a specialty pharmaceutical company based in San Diego.

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