UPDATED: FDA approves Actavis intrauterine device to prevent pregnancy

Liletta Intrauterine Contraceptive System--Courtesy of Actavis

Actavis ($ACT) announced FDA approval of its drug-delivering intrauterine device, Liletta, as a form of reversible contraception.

The T-shaped device delivers the drug levonorgestrel, and its dimensions are less than half than those of a standard playing card. Liletta is approved for use by women to prevent pregnancy for up to three years.

The therapy's launch is slated for the second quarter of this year, Actavis said in a release.

Morningstar analyst Michael Waterhouse told Reuters he expects annual sales for the product to be below $500 million. The main advantage of Liletta is convenience. Once a women has it implanted, "she doesn't need to do anything else for the full duration of use," said Liletta clinical trial investigator Dr. Carolyn Westhoff of Columbia University Medical Center in New York City, in an interview.

"This new hormonal IUD was proven more than 99 percent effective in the largest ever IUD trial conducted in the U.S. It offers a long-term, highly effective yet reversible option to prevent pregnancy for many women regardless of whether or not they've had a child before," said Dr. David L. Eisenberg, in a statement. An assistant professor of obstetrics and gynecology at Washington University in St. Louis, he is one of the clinical trial's investigators.

The trial is ongoing to evaluate the use of Liletta for up to 4, 5 and 7 years.

The device must be inserted by a trained healthcare provider. Westhoff said the one-minute in-office procedure is "just one step short of doing a pap test" and generally does not require local anesthetic.

It consists of a T-shaped plastic frame and hormone reservoir with membrane as well as blue removal threads. The reservoir contains 52 milligrams of levonorgestrel.

Westhoff said the drug's daily release rate through the membrane is stable, and declines by about 20% by the third year.

In partnership with nonprofit pharma company Medicines360, Liletta is going to be made available at a reduced cost to public health facilities that participate in the federal 340B Drug Pricing Program, Actavis says. "The intention in developing this IUD was to make sure the product would be available to all women and to improve access," Westhoff said.

Liletta will compete with Bayer's Mirena and Skyla hormonal IUDs and Teva's ($TEVA) copper-based IUD ParaGard.

- read the release
- here's Reuters' take

Editor's Note: This article has been updated with an interview of clinical trial investigator Dr. Carolyn Westhoff.

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