The latest and greatest in contraception, including new nonhormonal intrauterine devices (IUDs) and male birth control, was discussed during a presentation on updates in contraception at the 2022 American College of Obstetricians and Gynecologists’ Annual Clinical & Scientific Meeting held in San Diego, California from May 6-8.1
Kathleen Morrell, MD, MPH, director of Family Planning Division and residency program director in the Department of Obstetrics & Gynecology at Maimonides Medical Center in Brooklyn, New York, first outlined the IUDs that were just approved for use extension by the US Food and Drug Administration (FDA).
This includes Mirena (levonorgestrel-releasing intrauterine system; Bayer), which was approved to prevent pregnancy for up to 7 years by the FDA on August 11, 2021. Previously, Mirena was approved for use for up to 6 years. The approval was based on the Mirena Extension Trial, a multicenter study investigating the efficacy in preventing pregnancy, as well as treating heavy menstrual bleeding. Bayer plans on seeking approval for use for up 8 years.
Another IUD that was recently given approval for extended use is Liletta (levonorgestrel-releasing intrauterine system; AbbVie and Medicines360), which is now approved for up to 6 years and is expected to see a 7-year approval relatively soon.
What’s new on the market
Morrell also spoke on new contraceptives on the market, including Phexxi (lactic acid, citric acid, potassium bicarbonate; Evofem Biosciences), a vaginal pH modulator gel that is used within an hour before sex. She mentioned that sometimes insurance will cover it, but typically it costs $300 per 12-count box, equalizing out to roughly $25 per syringe. Additionally, Phexxi demonstrated 86% efficacy with typical use.
Nextstellis (drospirenone and estetrol tablets; Mayne Pharma) is another newly available contraceptive that was approved in April 2021. Drospirenone and estetrol is a new type of estrogen that is being labeled as a native estrogen with selective action in tissues, or NEST.
“Nextstellis is what I refer to as a potential game-changer in the world of contraception,” said Morrell.
Some of these “game-changing” qualities Nextstellis possesses include a half-life of 28 hours, a reduction of impact on hemostasis parameters, and a minimal first-pass metabolism. It is also currently being studied for multiple uses in reproductive health including hormone replacement therapy and menopause. However, Nextstellis does have a black box warning for smokers over the age of 35 for increased risk of cardiovascular events.
Next, Annovera (segesterone acetate and ethinyl estradiol vaginal system; TherapeuticsMD) was approved by the FDA in 2018. Patients will use the same ring every month for a year, leaving the ring in for 3 weeks and then leaving it out for 1 week, this will be repeated for 13 cycles. Morrell said the benefits of using Annovera are that it does not require refrigeration, the ring is thicker than the current ring on the market, and studies demonstrated 97.3% efficacy in preventing pregnancy.
Slynd (drospirenone; Exeltis) is a progestin-only pill approved by the FDA in 2019. It works by suppressing ovulation, while the current norethindrone pill works by thickening cervical mucus. This pill is a 24/4 regimen of drospirenone 4 mg/placebo with a half-life of 30 hours and in trials showed to be a longer-acting progestin than norethindrone. Morrell also mentioned a study that evaluated women missing the pill and found that even with multiple intentional 24-hour delays in tablet intake, ovulation suppression was still maintained.
Twirla (levonorgestrel and ethinyl estradiol transdermal system; Agile Therapeutics) is a patch that was approved by the FDA in February 2022. It has the same schedule as the current patch on the market (1 patch per week for 3 weeks, and then 1 week without). However, it contains a lower daily amount of released estrogen than the current patch (30 mcg vs 35 mcg). Morrell mentioned that there was a significant delay in the FDA approval of Twirla due to issues with the adhesive of the patch.
What’s in the pipeline?
Outside of mentioned new contraceptive methods, Morrell also outlined a few contraceptives in the pipeline. One of these up-and-coming contraceptives in the pipeline includes VerCept (Sebela Pharmaceuticals), an experimental, hormone-free, low-dose copper IUD, that is currently undergoing phase 3 trials.
Another contraceptive Morrell discussed was IIUB Ballerine (OCON Medical), a nonhormonal IUD that is similar to the copper coil IUD. Studies have shown that the device works for up to 5 years with >99% efficacy in preventing pregnancy. Currently, the IUB Ballerine is utilized in 30 countries, but it is not approved in the United States.
Also, OUI (Cirqle Biomedical), a nonhormonal vaginal capsule that thickens the mucus in the vagina, is another contraceptive currently making its way through the pipeline. Currently, it does not have any published data from human trials yet.
Morrell also touched upon an emerging market—male contraception. Two are currently being studied: a gel and a pill.
The gel, consisting of progesterone and testosterone, is rubbed onto the chest or shoulders daily. It works by turning off sperm production with progesterone and uses testosterone to counterbalance the loss of libido associated with progesterone.
A nonhormonal pill is also being studied in mice. In those trials, male mice were given the pill orally for 4 weeks. The pill works by targeting the protein retinoic acid receptor alpha (RAR-α). The study demonstrated a drastic reduction in sperm count in the male mice and was 99% effective in preventing pregnancy with no observable side effects. Additionally, after receiving the compound, the mice could father pups within 4-6 weeks. Morrell expects human trials to start in 2022.
Morrell reports being a trainer for Merck and was a former consultant for Mylan Pharmaceuticals.
1. Morrell K. Contraception 2022: What every ob-gyn needs to know. Presented at: 2022 American College of Obstetrics and Gynecology Annual Clinical & Scientific Meeting; May 6 to May 8, 2022.