Oral nalmefene hydrochloride, an opiate antagonist under development by Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), demonstrated positive results in a pilot Phase 2 clinical trial for smoking cessation.
Smokers dosed with nalmefene 40mg demonstrated numerically higher abstinence rates at all timepoints relative to placebo. In general, nalmefene was well tolerated but like what was observed in previous studies, adverse effects like nausea and insomnia occurred transiently but were largely tolerated after a week of being on the drug.
Approximately 45 million, or 22%, of adults in the United States are smokers (CDC, 2005) and cigarette smoking to this day remains the leading preventable cause of illness and premature death of Americans alone.
According to Ken Cohen, Somaxon's President and Chief Executive Officer:
"Nalmefene is a promising compound. We are currently studying this product in a large clinical trial for the treatment of pathological gambling. We intend to await the results of that trial, which we expect early next year, before we determine our further clinical development plans.
The results of this pilot smoking cessation trial give us the opportunity to potentially develop nalmefene for multiple indications in large markets with unmet medical needs."
Nalmefene is an opioid antagonist that has been approved and used over 10 years in the United States in an intravenous form for the reversal of opioid drug effects.
Somaxon is licensed to the North American development and commercial rights to an oral form of nalmefene and patents for its use in the treatment of impulse control disorders, nicotine dependence and other conditions.
Read more at Somaxon Pharma Inc. (a pdf file)
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