Lybrel To Launch In July Following FDA Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Wyeth’s oral contraceptive is the first continuous-use product without a placebo phase or pill-free interval.
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Wyeth will begin selling its continuous oral contraceptive Lybrel in July, the company told "The Pink Sheet" DAILY. FDA approved the product May 22. When the 28-day pill package reaches the market, Lybrel (0.02 mg ethinyl estradiol/0.09 mg levonorgestrel) will be the only contraceptive designed to be taken every day without a placebo phase or a pill-free interval. Women who continuously take Lybrel will not have a scheduled menstrual period, Wyeth and FDA noted. Wyeth said it does not plan to launch an immediate direct-to-consumer advertising campaign, but instead will focus efforts on educating doctors. FDA is requiring that Wyeth perform a postmarketing study of serious adverse events, such as thromboembolic events, "to see if there are any long-term effects that might be different than traditional oral contraceptives," CDER Office of Drug Evaluation III Deputy Director Daniel Shames said during a same-day conference call, adding that he does not anticipate any "surprises" with long-term use of Lybrel. Lybrel's approval is based on two one-year studies of more than 2,400 women. According to FDA, "the convenience of having no scheduled menstruation should be weighed against the inconvenience of unscheduled bleeding or spotting." In the primary study, 59 percent of women who took Lybrel for a year had no bleeding or spotting during the last month of treatment. Shames noted that about half of the women dropped out of the trial before one year. The approval follows a June 2006 "approvable" letter in which FDA asked Wyeth to submit additional stability data regarding Lybrel's manufacturing and additional analyses of submitted clinical data (1 (Also see "“Clinical Aspects” Of Wyeth’s Lybrel To Be Publicly Reviewed After “Approvable” Letter" - Pink Sheet, 28 Jun, 2006.)). Deficiencies in current Good Manufacturing Practice at Wyeth's Guayama, Puerto Rico, plant were also holding up approval. FDA gave its seal of approval in the form of a re-classification of the facility earlier this month (2 (Also see "FDA Clears Guayama Manufacturing Facility" - Pink Sheet, 9 May, 2007.)). Lybrel will likely compete with Barr's extended-cycle contraceptive Seasonique , which was approved in May 2006 and launched two months later. However, Seasonique's regimen includes 84 days of combination levonorgestrel and estrogen followed by seven days of unopposed estrogen (3 (Also see "Barr’s Seasonale Follow-On Clears FDA" - Pink Sheet, 26 May, 2006.)). - Jonathan M. Block ([email protected]) |