SeasoniqueTreatment for Contraception
Update: Seasonique Now FDA Approved - May 25, 2006
Duramed's Seasonique NDA Accepted for Filing by FDA
Represents Company's Second Proprietary Extended-Cycle Oral Contraceptive Product
WOODCLIFF LAKE, N.J., December 22, 2004 -- Barr Pharmaceuticals, Inc. (NYSE:BRL) today announced that its subsidiary, Duramed Pharmaceuticals, Inc., has received notification that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. The Company is seeking approval to manufacture and market Seasonique extended- cycle oral contraceptive for the prevention of pregnancy. The Prescription Drug User Fee Action (PDUFA) date for the Seasonique NDA is August 19, 2005.
"Seasonique represents our second entrant into the extended-cycle oral contraceptive product category we created with the launch of our Seasonale product last year. If ultimately approved by the FDA, it will join Seasonale in offering American women an additional, innovative option in birth control," said Dr. Carole S. Ben-Maimon, President and COO of Duramed Research. "While acceptance for filing of an NDA does not assure approval, we believe our clinical data indicates that the Seasonique extended-cycle oral contraceptive therapy prevents pregnancy and has a comparable safety profile to more traditional oral contraceptives."
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). An extension study of the pivotal trial is currently ongoing.
Under the Seasonique extended-cycle regimen, women take active tablets of 0.15 mg 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 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.
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.
Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Posted: December 2004
- FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive - May 27, 2006
- Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive - March 17, 2006
- Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive - August 18, 2005