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An Option to Explore for Preventing Menstrual Migraine

Seasonale Extended Cycle OC Approved

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Updated: October 1, 2003

Seasonale Approved

Women who experience Menstrually Associated Migraine (MAM) often explore various hormonal options for preventing MAM. Taking oral contraceptives continuously to avoid their period has been one option. One concern has been whether taking "the pill" that way was safe since they weren't developed for continuous use. Now, the FDA has approved Barr Laboratories' New Seasonale®, the first extended-cycle oral contraceptive.

First and Only Extended-Cycle OC Gives Women New Choice - Four Periods a Year

September 2003 (Newstream) -- Barr Laboratories, Inc. (NYSE-BRL) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's SEASONALE® (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets, an extended-cycle oral contraceptive for the prevention of pregnancy. SEASONALE, the first and only FDA-approved extended-cycle oral contraceptive, will be available by prescription to women at the end of October 2003.

The SEASONALE regimen is designed to reduce the number of periods from 13 to 4 per year. It is a 91-day regimen taken daily as 84 active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol, followed by 7 inactive tablets. By contrast, oral contraceptive products currently available in the United States are based on a 28-day regimen.

"The SEASONALE approval represents several 'firsts' for Barr. It is our first internally developed New Drug Application (NDA) product to gain FDA approval and we believe that it represents a significant advance in oral contraception," said Bruce L. Downey, Barr's Chairman and CEO. "The development of our SEASONALE product underscores Barr's commitment to women's health care, especially in the area of oral contraception. It is the first of what we believe will be several additional new drug applications for women's healthcare products over the next several years." SEASONALE was developed by Barr under an agreement with Eastern Virginia Medical School (EVMS).

"With today's approval of SEASONALE, women have a new choice when deciding on oral contraception," said Carole S. Ben-Maimon, M.D., President and COO of Barr Research. "For those women who prefer the convenience of fewer periods, SEASONALE offers a safe and effective alternative to the traditional 28-day oral contraceptive regimen."

The Company's 250-person Duramed Pharmaceuticals, Inc. women's healthcare sales force will promote the SEASONALE oral contraceptive directly to physicians and healthcare providers. Duramed is a wholly owned subsidiary of Barr Laboratories, Inc., resulting from the 2001 merger of Barr and Duramed. The Duramed sales force currently promotes Cenestin® (Synthetic Conjugated Estrogens, A).

Clinical Data

The clinical data supporting FDA approval of the SEASONALE® (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets product resulted from a randomized, open-label, multi-center trial that ended in March 2002 and an extension to that trial. In the trials, SEASONALE was found to prevent pregnancy and had a comparable safety profile to a more traditional oral contraceptive. In the trial, the most reported adverse events were nasopharyngitis, headache and intermenstrual bleeding or spotting.

SEASONALE has been formulated using well-established components, long recognized as safe and effective when used in a 28-day regimen. SEASONALE offers 4 periods per year as compared to 13 per year with traditional oral contraceptives. When prescribing SEASONALE, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting. A recently published Roper study found that when given the choice, nearly two-thirds of women would be interested in reducing their number of periods to 4 times per year.¹

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