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FDA Approves Extended-Cycle Oral Contraceptive
SEASONIQUE will be shipped to trade customers and will be available by prescription to women in July 2006. The Company intends to immediately initiate multiple marketing programs aimed at healthcare providers and patients. The Company will initiate full scale detailing for SEASONIQUE to healthcare providers in August using its Duramed Sales Forces. Information about SEASONIQUE will be available at http://www.seasonique.com/.
"SEASONIQUE joins SEASONALE in offering American women a new option in extended-cycle oral contraception," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "The science involving extended-cycle oral contraceptives continues to evolve and SEASONIQUE represents an exciting and unique development in this category. SEASONIQUE provides continuous hormonal support in the form of a low-dose of estrogen in place of the seven placebo pills. There is no other product like SEASONIQUE on the market today."
Downey continued, "We believe that our SEASONIQUE product line, including our Lo SEASONIQUE(TM) product that is currently in Phase III clinical studies, as well as other extended-cycle oral contraceptive products also in development, expands our commitment and leadership to a franchise that provides women with the option of four periods per year and low dose estrogen instead of a hormonal free interval."
The Company's application for SEASONIQUE had received an Approvable Letter in August 2005. In March 2006, the FDA notified the Company that it had determined that additional clinical studies would not be required to support the approval of SEASONIQUE. Following this notification, the Company submitted product labeling that has now gained approval.
Under the SEASONIQUE extended-cycle regimen, women take active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year. The clinical data supporting the SEASONIQUE NDA resulted from one large pivotal randomized, open-label, multi-center trial and one supportive randomized, open-label, multi-center trial, both of which ended in April 2004. The trials involved approximately 2,500 female patients between the ages of 18-40 at 43 sites in the United States. Patients were enrolled in the pivotal trial for the duration of 12 months (four (4) 91-day cycles).
Important Information About Oral Contraceptives
It is estimated that more than 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Source: Barr Pharmaceuticals, Inc.