Newly Published Data from Phase 3 Clinical Trial of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Confirms Efficacy, Safety, and Tolerability Through Five Years

SAN FRANCISCO, Dec. 10, 2018 /PRNewswire/ -- Medicines360, a global nonprofit women's health pharmaceutical company, announced newly published data finding that LILETTA is highly efficacious in preventing pregnancy over five years of use. In addition, the publication reports data related to the bleeding profile of LILETTA over the same time period. "Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52 mg Intrauterine System" was recently published online by the American Journal of Obstetrics & Gynecology.

The findings are based on the largest ongoing Phase 3 intrauterine system (IUS) clinical trial in the U.S. The trial, "ACCESS IUS," (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), follows 1,751 U.S. women who received LILETTA. According to the study, LILETTA is more than 99 percent effective in preventing pregnancy for up to five years in a broad range of women. LILETTA is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

This latest study publication from the ACCESS IUS trial also describes rates of amenorrhea (defined as no bleeding or spotting in the preceding 90 days) for LILETTA through five years of continued use. The study reported that nearly half (42 percent) of the women in the trial had amenorrhea at the end of five years of use. During the same time period, 90 percent of women experienced only amenorrhea, spotting, or light bleeding. In the trial, 2.2% of women discontinued the use of LILETTA due to bleeding complaints.

Medicines360 received initial FDA approval of LILETTA in February 2015 and in October 2018, the product received an updated indication for up to five years of pregnancy prevention. Since it was introduced in 2015, Medicines360 and Allergan, a global pharmaceutical company, have partnered to expand access to LILETTA to women regardless of income or insurance coverage.

"It's our mission to increase access to effective health care for all women. The latest results from ACCESS IUS are extremely encouraging as they demonstrate LILETTA's effectiveness and safety for pregnancy prevention in a broad range of women and provide insight into its bleeding profile," said Jessica Grossman, M.D., CEO of Medicines360. "Coupled with our nonprofit business model, we hope this new evidence leads to more clinics offering more women affordable long-acting reversible contraception options."

The cost of contraception can prohibit many women from obtaining an option that is appropriate for them. This is a significant public health concern. As a nonprofit pharmaceutical company committed to addressing gaps in access to women's healthcare, Medicines360 continues to pursue affordable and effective solutions that work for all women.

"As more women in the U.S. request long-acting reversible contraception, especially hormonal IUSs, demonstrating a five-year duration of use for LILETTA is important for both women's health and public health," said Mitchell D. Creinin, M.D., Professor of Obstetrics and Gynecology and Director of Family Planning at the University of California, Davis and an author of the manuscript. "When an IUS, such as LILETTA, is approved for a longer duration of use, women may see potential benefits such as fewer insertion and removal procedures, which in turn may help decrease healthcare costs over time."

Medicines360 sponsored and designed the ACCESS IUS study and oversees its conduct, including funding the trial and providing all study product free of charge to participants.

ABOUT LILETTA^®

Indication

LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years.

Important Risk Information About LILETTA

• Do not use LILETTA if you:
• Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
• Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
• Have an untreated lower genital infection now
• Have had an infection from an abortion within the last 3 months
• Can get infections easily; for example, if you:
• Have problems with your immune system
• Have multiple sexual partners or your partner has multiple sexual partners
• Use or abuse intravenous drugs
• Have or suspect you might have cancer of the uterus or cervix
• Have bleeding from the vagina that has not been explained
• Have short-term (acute) liver disease or liver tumor
• Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
• Have an intrauterine system (IUS) in your uterus already
• Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
• Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate
• Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding, infertility and even death. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection, miscarriage and premature labor or delivery can occur with pregnancies that continue with an IUS
• Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
• Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop
• Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
• Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
• LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women
• LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
• Ovarian cysts may occur and usually disappear on their own, but some may require surgery

LILETTA does not protect against HIV or STDs.

For full prescribing information, visit www.LILETTA.com.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

SOURCE Medicines360