FDA approves intrauterine device, Liletta, for pregnancy prevention

Actavis and Medicines360 announced today that the FDA has granted approval to intrauterine device, Liletta, for the prevention of pregnancy for up to 3 years.

“The FDA’s approval of Liletta marks an important milestone for women, providers and the reproductive health community. Liletta was designed from the beginning to be accessible by women, regardless of socioeconomic status,” Pamela Weir, chief operating officer at Medicines360, said in a press release.  

Liletta is a small, flexible plastic T-shaped intrauterine device (IUD), measuring 32 mm by 32 mm. The device slowly releases levonorgestrel, with an initial release rate of 18.6 µg/day followed by an average in vivo release rate of roughly 15.6 µg/day over a 3-year period. Liletta can be inserted by a provider at any time, as long as the patient is not pregnant, and can also be removed at any time.

The FDA based the approval on results from A Comprehensive Contraceptive Efficacy & Safety Study of an IUS (ACCESS IUS), the largest hormonal IUD trial conducted in the U.S. Researchers evaluated 1,751 women that received Liletta and found a 3 year efficacy rate of 99.45%, regardless of previous births, BMI or age. The ACCESS IUS trial remains ongoing to evaluate the efficacy of Liletta for up to 4, 5 and 7 years. 

Common side effects associated with Liletta include vaginal infections, vulvovaginal infections, acne, headache or migraine, nausea or vomiting, dyspareunia, abdominal discomfort or pain, breast tenderness or pain, pelvic discomfort or pain, depression or depressed mood and mood changes. Serious complications included expulsion, sepsis, perforation and ovarian cysts.

Providers should use caution with Liletta in patients with coagulopathy or who are taking anticoagulants or who have migraines, severe headaches, marked increased blood pressure or severe arterial disease.

Liletta is not appropriate for women who are currently pregnant or may become pregnant, or who have uterine anomalies, past or present known or suspected breast cancer, liver disease, untreated acute cervicitis or vaginitis, postpartum endometritis or infected pregnancy within the last 3 months, unexplained uterine bleeding, current IUD, acute pelvic inflammatory disease (PID) or a history of PID, known or suspected uterine or cervical neoplasia, conditions increasing susceptibility to pelvic infections or hypersensitivity to any component of Liletta.