Oral Dissolvable Birth Control Pill Receives Approval From the FDA

The FDA approved norethindrone acetate and ethinyl estradiol (Femlyv; Teva Pharmaceuticals, Inc), an oral dissolvable birth control pill, for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol have been approved in the US as a swallowable tablet since 1968. The manufacturing of an oral dissolvable expands contraceptive access to patients who have difficulty swallowing.

The tablet is meant to be dissolved on the tongue followed by 8 oz of water and taken around the same time every day. Image Credit: © Natee Meepian - stock.adobe.com

Birth control pills are a hormonal treatment commonly used to prevent pregnancy; however, they have other beneficial applications in managing endometriosis, polycystic ovary syndrome, menstrual symptoms, irregular menstrual cycles, and premenstrual dysphoric disorder (PMDD). Many of these conditions can be debilitating with significant quality of life implications for affected individuals. Hormonal contraceptives typically involve either 1 or a combination of estrogen and progestin and are available as oral medications, patches, injections, and intrauterine devices.¹

Birth control pills and contraceptives are subject to persistent scrutiny due to the health concerns surrounding interrupting natural hormonal cycles. Although, studies have shown that these treatments are safe, efficacious, and in some cases necessary for pain management, symptom reduction, and preventing worsening disease. In endometriosis treatment, birth control can help reduce endometrial-like tissues development outside the uterus, reduce inflammation, and manage pain, and are the most popular treatment method for endometriosis in the US.^2,3

Norethindrone acetate and ethinyl estradiol is the first oral dissolvable contraceptive approved by the FDA, marking another step in advancing access to personalized treatment for all patients. The decision is based on positive results from a study involving 743 women ages 18 to 45 who received the tablets for up to 6 28-day cycles. At the end of the 6 cycles, 5 of the 583 women had on-treatment pregnancies within 3,565 treatment cycles.⁴

The most common reported adverse effects (AEs) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. Of the participants, 6% discontinued treatment due to an AE.⁴

Norethindrone acetate and ethinyl estradiol comes in a packet of 28 tablets with differentiated colored tablets, of which there are 24 green active doses and 4 white inert tablets. The tablet is meant to be dissolved on the tongue followed by 8 oz of water and taken around the same time every day.⁴

“[Norethindrone acetate and ethinyl estradiol] is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press release. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”⁵

References

1. Birth control pill. Planned Parenthood. Accessed July 24, 2024. https://www.plannedparenthood.org/learn/birth-control/birth-control-pill

2. Birth control for endometriosis: does it work? Revive Research Institute. June 22, 2022. Accessed July 24, 2024. https://www.reviveresearch.org/blog/birth-control-for-endometriosis/

3. Can birth control help with cramps? TeensHealth. May 2024. Accessed July 24, 2024. https://kidshealth.org/en/teens/cramps.html#:~:text=Hormonal%20birth%20control%20lowers%20the,That%20means%20there's%20less%20pain

4. FDA oks first orally dissolving birth control pill. MedPage Today. July 24, 2024. Accessed July 24, 2024. https://www.medpagetoday.com/obgyn/pregnancy/111217?xid=nl_mpt_morningbreak2024-07-24&mh=6d2b5f4f91352444bdf817a9c17750bc&utm_source=Sailthru&utm_medium=email&utm_campaign=MorningBreak_072424&utm_term=NL_Gen_Int_Daily_News_Update_active

5. FDA roundup: July 23, 2024. FDA. July 23, 2024. Accessed July 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-july-23-2024