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US FDA approval for LoSeasonique

This article was originally published in Scrip

Executive Summary

The Barr Pharmaceuticalssubsidiary Duramed Pharmaceuticals has received US FDAapproval for LoSeasonique, its new low-dose version of the extended-cycle oral contraceptive Seasonique. LoSeasonique (levonorgestrel/ethinylestradiol tablets 0.10mg/0.02mg and ethinylestradiol tablets 0.01mg) is the first lower-dose, extended-cycle oral contraceptive, Barr says, and is due to be launched early next year, when Duramed will begin promotion to healthcare providers. Under the LoSeasonique regimen, combination tablets of the two hormones are taken for 84 consecutive days followed by the ethinylestradiol tablets for seven days. The higher dose product, Seasonique, which comprises pills containing 0.15mg of levonorgestrel and 0.03mg of ethinylestradiol for 84 days followed by seven days of 0.01mg ethinylestradiol, was launched in the US in 2006, while Barr's Seasonale (which has the same regimen as Seasonique but with a seven-day placebo period rather than ethinylestradiol) was launched in 2003. All three products result in three menstrual periods a year, rather than 13 with standard oral contraceptives. Wyeth's Lybrel (0.09mg levonorgestrel plus 0.02mg ethinylestradiol) became the first oral contraceptive to eliminate menstruation when it received FDA approval in 2007 (Scrip Online, May 24th, 2007).



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