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FDA approves weekly contraceptive patch

Author(s): By Dave Gilmartin
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The U.S. Food and Drug Administration has approved a once-weekly combined hormonal patch (CHC) with low-dose estrogen, Viatris Inc. announced last week.

Viatris’ patch, Gwyn Lo, is expected to be available later this year. It is applied weekly for three consecutive week followed by an off week.

It is contraindicated in women who smoke, over 30 BMI or are over 35 years of age due to an increased risk of cardiovascular events.

“Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen,” said Philippe Martin, Viatris Chief R&D Officer.

The FDA approval came after a Phase 3 Luminous Study that demonstrated contraceptive efficacy, well-characterized safety profile and robust patch adhesion, with only 1.3% of 39,790 patches detaching during the year-long trial. A Phase 1 trial further found consistent adhesion under a variety of conditions including sauna, whirlpool, treadmill exercise and cold-water bath, the company reported.

 

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