The US Food and Drug Administration has issued an approvable letter for Duramed Pharmaceuticals, Inc.'s 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. To achieve final approval, the FDA has requested that the company to provide additional data to support Seasonique's unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen. Once approved, the company intends to market Seasonique for the prevention of pregnancy in women who choose to take hormone products for contraception, release from Barr Labs said.
The company had launched the Seasonale extended-cycle oral contraceptive in 2003. In addition to Seasonique, the company's pipeline of extended-cycle oral contraceptive products also includes a NDA currently pending at the FDA for Seasonale Lo (levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets) extended-cycle oral contraceptive.
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 monthly to four per year.
The clinical data supporting the Seasonique NDA resulted from one large pivotal randomized, open-label, multi-centre trial and one supportive randomized, open-label, multi-centre 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. An extension study of the pivotal trial is currently ongoing.