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Newly Published Data from Phase 3 Clinical Trial of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Reinforces Efficacy for Longest-Approved Duration of Use for a Hormonal IUS

SAN FRANCISCO – December 17, 2019 Medicines360, a global nonprofit women’s health pharmaceutical company, announced newly published data finding that LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg is highly efficacious in preventing pregnancy for up to six years of use. The publication also reports data related to the bleeding profile over the same period of time.  “Six-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52 mg Intrauterine System,” was recently published online and will appear in the January 2020 print issue of Contraception. In October 2019, LILETTA received an updated indication for up to six years of pregnancy prevention, making it the longest approved duration of use for any hormonal intrauterine system (IUS, also known as an intrauterine device or IUD) in the U.S.  Medicines360 received initial FDA approval of LILETTA in February 2015.

The findings are based on the largest Phase 3 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 demonstrated over 99% effectiveness in preventing pregnancy for up to 6 years in a diverse population of women.

“High costs of medicines can prohibit many women from obtaining a birth control option that is most appropriate for them, leading to an inequitable healthcare system,” said Jessica Grossman, M.D., CEO of Medicines360. “As a nonprofit committed to filling gaps in women’s healthcare, it’s our mission to ensure that cost never stands in the way of women and the medicines they need.”

The most recent study publication from the ACCESS IUS trial also provides data regarding amenorrhea (defined as no bleeding or spotting in the preceding 90 days) for LILETTA through six years of continued use. According to the study, approximately 40% of the women in the trial reported amenorrhea at the end of six years of use.

“This pivotal Phase 3 study provides the most robust information to date on the clinical efficacy of a 52 mg hormonal IUD for pregnancy prevention beyond 5 years in a diverse population of women, 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 publication. When women have long-acting and reversible options such as LILETTA, they stand to see potential benefits including fewer insertion and removal procedures, which in turn may help decrease healthcare costs.”

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 6 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. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection 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 partially go into (become embedded) or go completely through (perforate) the wall of the uterus. If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have LILETTA removed if it is embedded or perforation occurs. 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 but usually disappear

LILETTA does not protect against HIV or STDs.

Available by prescription only.

Please see full Prescribing Information for LILETTA.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical company with a mission to remove cost as a barrier to health by developing and providing affordable Women’s Health products. 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

 

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