Barr Pulls Lo Seasonale Filing

The company withdraws its application, saying the FDA might have wanted a larger clinical trial.
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Barr Pharmaceuticals

(BRL)

said Thursday that it has withdrawn its application to market Lo Seasonale, an oral contraceptive that enables women to reduce their menstrual periods to quarterly from monthly.

Lo Seasonale is a lower-dose variation of Seasonale, which entered the market in November 2003 and is unaffected by Barr's decision. Barr said it ended its Lo Seasonale bid following discussions with the Food and Drug Administration. Those talks led the company to conclude that it may have had to conduct a larger clinical trial to obtain FDA approval.

"Rather than continue to devote additional resources to the Lo Seasonale

application, we have made the strategic decision to withdraw the application," said Bruce L. Downey, the chairman and CEO, in a prepared statement.

The announcement sent Barr's stock down $1.16, or 1.8%, to $62.96. Barr filed its Lo Seasonale documents with the FDA last June, and the agency had been scheduled to rule on April 24.

Downey said his company continues to work on other oral contraceptives, including Seasonique and Lo Seasonique. "We remain committed to developing a franchise of extended-cycle products, and believe that the Seasonique products will ultimately become the flagships of our extended-cycle oral contraceptive franchise," he said.

Barr's extended-cycle oral contraceptives have experienced several delays with the FDA. In August, Barr received

conditional approval from the FDA for Seasonique. At the time, the company didn't provide details of the FDA's concerns or a timetable for meeting the agency's conditions.

Last month, the company said Seasonique wouldn't need extra clinical trials. Barr "is continuing to work with FDA to resolve outstanding issues including product labeling and postmarketing commitments," the company said Thursday. Seasonique will be launched "in the near future," it added.

Seasonique requires women to take a pill combining levonorgestrel and ethinyl estradiol for 84 consecutive days, followed by seven days of ethinyl estradiol. Barr's application to the FDA is based on two clinical trials, involving around 2,500 women, that were completed two years ago. The women were treated for 12 months, and an extension study is continuing.

Lo Seasonique includes a lower-dose of the combination pill for 84 consecutive days, followed by seven days of ethinyl estradiol. Barr said the clinical trial supporting this product will be completed by June 30, 2007. The company expects to seek FDA approval by the end of next year.

The Seasonique drugs differ from Seasonale, the matriarch of extended-cycle oral contraceptives. The Seasonale regimen involves 84 days of the combination pill followed by seven days of a placebo.

The FDA was supposed to act on Seasonale in May 2003, but said it needed more time to review the product. The agency approved Seasonale in September 2003, and the drug reached the market two months later.