Somaxon may head for OTC status in USA for Insomnia

Somaxon Pharmaceuticals is likely to seek regulatory approval in the USA for an over-the-counter version of Silenor (low dose doxepin). A recent meeting at the FDA seemed positive. The marketing of Silenor with Proctor & Gamble launched 12 months ago has not been successful due to low cost competition from generic versions of Ambien and Ambien CR (extended-release zolpidem).Somaxon plans to discontinue the co-promotion services of Proctor & Gamble at the end of this year but is interested in discussing marketing of the OTC version with Proctor & Gamble. The OTC version launch maybe still several years away. Somaxon is also facing generic challenges to the drug.Paladin Labs has rights in Canada, Latin America and Africa.