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Opill

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Opill
Background
TypeProgestin-only Pill
First useMarch 2024
Pregnancy rates (first year)
Perfect use2%
Typical use9%
Usage
User remindersDaily, within the same 3 hour period
Advantages and disadvantages
STI protectionNo
BenefitsOTC, no prescription required

Opill is a birth control pill formulated from norgestrel, which works to thicken the cervical mucus and prevent pregnancy.[1] Opill is manufactured by HRA Pharma and is the first ever over-the-counter contraceptive to be sold in the United States.[2] Opill is solely intended to be used for pregnancy prevention. It is not intended for use in emergency situations or for prevention of sexually transmitted diseases or infections.[3] Opill is marketed through social media and its partnership with the Women's National Basketball Association (WNBA).[4]

History

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Opill was acquired by Perrigo during their acquisition of HRA Pharma, along with ellaOne and Hana, other over-the-counter emergency contraceptives.[5]

Opill was approved by the Food and Drug Administration (FDA) for over-the-counter use on July 13, 2023.[2] This approval was given to its manufacturer a year after their initial application for the prescription to over-the-counter switch.[6] This came a year after the overturning of Roe v. Wade, which heavily restricted or criminalized abortion in 24 states.[7]

Opill began sale at major retailers in the U.S., including CVS, Target, Walgreens, and Walmart in March 2024. It is also available online from the Opill website and Amazon.[8]

Product

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Opill is a progestin-only daily birth control pill, also known as a “mini pill,” available over-the-counter without the need for health insurance.[1][3] It has no age restrictions and is safe to use as long as menstruation has started. The pill should be taken orally at the same time each day for optimal effectiveness; it is 98% effective when taken correctly and 91% effective with typical use.[1][9] Opill begins working 48 hours after the first dose.[10]

Opill is intended solely as a contraceptive and does not function as emergency contraception, provide protection against sexually transmitted infections (STIs), or act as an abortion medication.[3] Common side effects include irregular vaginal bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, bloating, and cramping.[2]

Opill can be purchased online through the company’s website or found in the family planning aisles of most drug stores, convenience stores, and grocery stores. Opill's presence in the family planning aisle could help reduce the U.S.' unplanned pregnancy rate of 41.6% as of 2019.[11][12]

Marketing

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When it comes to testing and labeling, Opill used several surveys to make sure that consumers could follow the instructions on dosing and understand the package labels.[13] This is an important step to the brand since consumers take the medication without doctor supervision. The colors of the packaging are also designed with the idea of avoiding gender-based stereotypes. They use a variety of colors, mainly teal with accents of blue, purple, and pink.[13] This variety of bright colors not only sets Opill apart, but it helps consumers gain brand recognition.

Opill also works with Snapchat to spread awareness to Generation Z. The results of the campaign report an increase in brand awareness by 24%.[14] According to Leila Bahbah, US Women's Health Brand Lead and Associate Director of Opill, Snapchat was a key player in reaching Gen Z audiences.[14]

In April 2024, Perrigo partnered with The Women's National Basketball Association to work together to build confidence and health equity. Colie Edison, Chief Growth Officer for the WNBA, said that the WNBA is dedicated to addressing issues important to the organization such as reproductive health.[4] This is why this multi-year partnership aligns with both Perrigo and WNBA's core beliefs. They are working to increase accessibility and reach students on college campuses across the country.[4]

Scientific foundation

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Norgestrel is a progestin used in birth control pills, such as the Opill, which contains a synthetic version of the naturally occurring hormone progesterone.[1][15] The Opill contains 0.075mg of the active ingredient norgestrel, along with inactive ingredients including cellulose, FD&C Yellow 5, lactose, magnesium stearate, and polacrilin potassium.[16]

The Opill primarily works by thickening the cervical mucus, making it harder for sperm to reach the egg.[10][17] It can also prevent the release of eggs from the ovaries during some menstrual cycles and thins the uterine lining, creating a less hospitable environment for a fertilized egg to implant.[10][16]

Progesterone plays a crucial role in preventing pregnancy by stopping ovulation. It works by inhibiting the development of ovarian follicles, preventing the release of an egg. This process is regulated by negative feedback on the hypothalamus, reducing the secretion of hormones like follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Without follicle development, estradiol levels remain low and the LH surge necessary for ovulation is blocked, effectively preventing ovulation.[16][18]

Availability

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Opill is currently available in all states in the U.S. after it was approved by the FDA on July 13, 2023. The active ingredient in Opill, Norgestrel, was legalized for prescription use in 1973. However, it was discontinued by the manufacturer in 2005.[1] Opill is available in major retailers like Walmart, Target, CVS, and Walgreens. In stores, a one month supply is sold for $19.99, and a three month supply is sold for 49.99.[19] Perrigo also offers a "Cost Assistance Reduction" program for those that are eligible.

Currently, there are no legal restrictions placed on the Opill, however, that could change as it did with the oral abortion pill Mifepristone.[11]

World wide, over-the-counter birth control is legal in most of Africa, South America, and Asia. However, in most of Europe it still requires a prescription.[20]

References

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  1. ^ a b c d e Research, Center for Drug Evaluation and (2024-07-12). "Opill (0.075mg Oral Norgestrel Tablet) Information". FDA.
  2. ^ a b c Commissioner, Office of the (2024-08-09). "FDA Approves First Nonprescription Daily Oral Contraceptive". FDA. Retrieved 2024-10-07.
  3. ^ a b c "Five Things to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill". NYU Langone News. Retrieved 2024-10-06.
  4. ^ a b c "Opill and WNBA Team Up for Groundbreaking Partnership". Opill.
  5. ^ "Perrigo to Acquire Leading Consumer Self-Care Company, HRA Pharma". Perrigo InvestorRoom. Retrieved 2024-10-07.
  6. ^ "Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill - Drugs.com MedNews". Drugs.com. Retrieved 2024-10-07.
  7. ^ "Six Months Post-Roe, 24 US States Have Banned Abortion or Are Likely to Do So: A Roundup | Guttmacher Institute". www.guttmacher.org. 2023-01-09. Retrieved 2024-10-07.
  8. ^ Lupkin, Sidney (2024-03-04). "First over-the-counter birth control pill now for sale online". NPR. Retrieved 2024-10-06.
  9. ^ "What you need to know about Opill, the first over-the-counter birth control | OHSU". www.ohsu.edu. Retrieved 2024-10-06.
  10. ^ a b c "About Opill | The First Over-the-Counter Birth Control Pill". Opill. Retrieved 2024-10-06.
  11. ^ a b "Opill: The First Over-the-Counter Daily Oral Contraceptive | Johns Hopkins | Bloomberg School of Public Health". publichealth.jhu.edu. 2023-07-13. Retrieved 2024-10-07.
  12. ^ CDC (2024-05-20). "Unintended Pregnancy". Reproductive Health. Retrieved 2024-10-07.
  13. ^ a b "Our Story". Opill.
  14. ^ a b "How Opill Made Birth Control More Accessible With Snapchat Ads". Snapchat Business.
  15. ^ Pitkin, R. M. (August 1995). "Editorial". Obstetrics & Gynecology. 86 (2): 293. doi:10.1016/0029-7844(95)00162-k. ISSN 0029-7844. PMID 7617364.
  16. ^ a b c “Opill Tablets.” FDA Data Access, FDA, www.accessdata.fda.gov/drugsatfda_docs/label/2017/017031s035s036lbl.pdf. Accessed 6 Oct. 2024.
  17. ^ "What You Need to Know About Opill, the First FDA-Approved Over-the-Counter Birth Control Pill | University of Utah Health". healthcare.utah.edu. 2023-07-28. Retrieved 2024-10-06.
  18. ^ Cooper, Danielle B.; Patel, Preeti (2024-02-29), "Oral Contraceptive Pills", StatPearls [Internet], StatPearls Publishing, PMID 28613632, retrieved 2024-10-06
  19. ^ "Opill, first U.S. over-the-counter birth-control pill, to hit stores: What to know". Washington Post. 2024-03-05. Retrieved 2024-10-06.
  20. ^ "OTC Access World Map". Free The Pill. Retrieved 2024-10-06.
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