Bayer get approval on Skyla
PITTSBURGH, PA: U.S. regulators on Wednesday approved a new low-dose hormone intrauterine device designed to prevent pregnancy, the first new device of its type in 12 years, according to Bayer AG.
The T-shaped polyethylene device is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin, according to Bayer documents.
The proportion of women using long-acting reversible contraceptive methods such as an intrauterine device (IUD) climbed to 7.7 percent in 2009 up from 2.0 percent in 2002, according a 2012 study by the Guttmacher Institute, a reproductive health and rights organization based in New York.
The highest level of use was among women aged 25-39 and those who already had at least one child.
The IUD, called Skyla, is aimed at younger women who have not had children. During a trial of 1,432 women aged 18 to 35 years, the rate of pregnancy over a three-year period was 0.9 per 100 women, and 77 percent of women wishing to become pregnant did so within 12 months of its removal, Bayer documents said.
“Over half of all pregnancies in the U.S. are unintended and there’s just a need out there to have effective birth control,” said Pamela Cyrus, Bayer’s head of medical affairs said in an interview.
Bayer makes one of the two other IUDs available on the U.S. market, Mirena. It is designed for use for women who have already had children.
Bayer will launch Skyla in the United States starting next month. It is still seeking other regulatory approvals outside the United States. Its side effects include bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst and headache.