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Bayer gains FDA nod for long-use IUD

The approved device is the first of its kind to reach the FDA finish line in 12 years
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For the first time in 12 years, the U.S. has a new IUD approved for commercial use, and Bayer is bringing it to market in early February.

The company announced this week that it gained FDA approval for Skyla, a hormone-releasing intrauterine birth control device designed to be implanted for up to three years. Skyla, a prescription-only device, is a T-shaped implant that is 28mm x 30mm and slowly releases the hormone levonorgestrel into the uterus over time.

Bayer promotes the device/drug combo as an improvement, in part because it lasts longer term. Bayer gained approval, in part, from promising data generated by a Phase III trial involving 1,432 women ages 18 to 35.

A new product in the birth control space is a smart move because of steady demand and the need for more options. Bayer cites statistics that show nearly half of all pregnancies in the U.S. are unintended, which creates an opening for companies who can address that need with education and market new IUD or related birth control products. IUD use is also on the rise. According to statistics cited by Reuters, use of intrauterine devices climbed to 7.7% of the market in 2009, a steady rise from 2% in 2002. And Bayer already can stake claim to one of only two IUDs approved for sale in the U.S. (Mirena),  the story notes.

Beyond birth control IUDs have gotten greater research attention in recent months. Earlier in mid-2012, for example, a new study determined that IUDs could help prevent unwanted pregnancies more effectively than the pill, patch or other ring-type birth control products. Scientists are also testing the device as a possible way to treat early-stage endometrioid adenocarcinoma, a common endometrial cancer, or atypical endometrial hyperplasia, a thickening of the womb lining that can lead to cancer.

- read the release

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